--- title: Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants nct_id: NCT02096263 overall_status: COMPLETED phase: PHASE3 sponsor: GlaxoSmithKline study_type: INTERVENTIONAL primary_condition: Poliomyelitis countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02096263.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02096263" ct_last_update_post_date: 2019-11-27 last_seen_at: "2026-05-12T07:25:30.925Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants **Official Title:** Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants **NCT ID:** [NCT02096263](https://clinicaltrials.gov/study/NCT02096263) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 585 - **Lead Sponsor:** GlaxoSmithKline - **Conditions:** Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Tetanus, Acellular Pertussis, Hepatitis B - **Start Date:** 2014-04-16 - **Completion Date:** 2015-11-13 - **CT.gov Last Update:** 2019-11-27 ## Brief Summary The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age. ## Eligibility - **Minimum age:** 6 Weeks - **Maximum age:** 12 Weeks - **Sex:** ALL - **Healthy Volunteers:** Yes ``` Inclusion Criteria: * Subjects' parent(s)/ Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Born full-term (i.e. after a gestation period of 37 weeks to less than 42 completed weeks \[259 to 293 days\]). * Written informed consent obtained from parent(s)/LAR(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment. Exclusion Criteria: * Child in care * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. * Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting from 30 days before the first vaccination until 30 days after Dose 3 (Epoch 001, primary vaccination) and from 30 days before the booster Dose 4 until 30 days after booster Dose 4 (Epoch 002, booster vaccination), i.e. the end of the study: * Inactivated influenza and hepatitis A vaccines are allowed throughout the study. * Routine administration(s) of vaccines are allowed from 30 days after the last dose of primary vaccination until 30 days before the booster dose and after post-booster blood sampling. Routine administration of measles-mumps-rubella vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last dose of primary vaccine until 30 days before booster dose and from post-booster blood sampling, as well as according to the recommended immunization schedule in US. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * History of Hib, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus and hepatitis B diseases. * Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (including yeast). * Hypersensitivity to latex. * Major congenital defects or serious chronic illness. * History of any neurological disorders including seizures. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * History of intussusception or of any uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception. * History of Severe Combined Immunodeficiency Disease (SCID). * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥38.0°C /100.4°F by any route. The preferred route for recording temperature in this study will be rectal for Epoch 001 and axillary for Epoch 002. * Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. ``` ## Arms - **Infanrix hexa Group** (EXPERIMENTAL) — Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh. - **Pediarix Group** (ACTIVE_COMPARATOR) — Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh. - **Pentacel Group** (ACTIVE_COMPARATOR) — Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh. ## Interventions - **Infanrix hexa** (BIOLOGICAL) — 3 doses administered intramuscularly in the right thigh. - **Pediarix** (BIOLOGICAL) — 3 doses administered intramuscularly in the right thigh - **ActHIB** (BIOLOGICAL) — 4 doses administered intramuscularly in the upper left thigh - **Pentacel** (BIOLOGICAL) — 4 doses administered intramuscularly in the right thigh - **Engerix-B** (BIOLOGICAL) — 2 or 3 doses administered intramuscularly in the upper left thigh - **Infanrix** (BIOLOGICAL) — 1 dose administered intramuscularly in the right thigh - **Hiberix** (BIOLOGICAL) — 1 dose administered intramuscularly in the left thigh - **Prevnar13** (BIOLOGICAL) — 3 doses administered intramuscularly in the lower left thigh - **Rotarix** (BIOLOGICAL) — 2 doses administered orally ## Primary Outcomes - **Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).** _(time frame: At Month 5, one month after the third dose of the primary vaccination.)_ — Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables. ## Secondary Outcomes - **Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.** _(time frame: At Month 5, one month after the third dose of the primary vaccination.)_ - **Number of Seroprotected Subjects Against Tetanus (T).** _(time frame: At Month 5, one month after the third dose of the primary vaccination.)_ - **Number of Seroprotected Subjects Against Diphtheria (D).** _(time frame: At Month 5, one month after the third dose of the primary vaccination.)_ - **Antibody Concentrations for Anti-T.** _(time frame: At Month 5, one month after the third dose of the primary vaccination)_ - **Antibody Concentrations for Anti-D.** _(time frame: At Month 5, one month after the third dose of the primary vaccination)_ - **Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.** _(time frame: At Month 5, one month after the third dose of the primary vaccination)_ - **Antibody Titres for Anti-polio Types 1, 2 and 3.** _(time frame: At Month 5, one month after the third dose of the primary vaccination)_ - **Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP).** _(time frame: At Month 5, one month after the third dose of the primary vaccination)_ - **Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.** _(time frame: At Month 5, one month after the third dose of the primary vaccination)_ - **Antibody Concentrations for Anti-PRP.** _(time frame: At Month 5, one month after the third dose of the primary vaccination)_ - **Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs).** _(time frame: At Month 5, one month after the third dose of the primary vaccination)_ - **Antibody Concentrations for Anti-HBs.** _(time frame: At Month 5, one month after the third dose of the primary vaccination)_ - **Number of Subjects With Solicited Local Symptoms.** _(time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 1)_ - **Number of Subjects With Solicited Local Symptoms.** _(time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 2)_ - **Number of Subjects With Solicited Local Symptoms.** _(time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 3)_ - **Number of Subjects With Solicited Local Symptoms.** _(time frame: During the 4-day (Days 0-3) post-vaccination period following any dose.)_ - **Number of Subjects With Solicited General Symptoms.** _(time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 1.)_ - **Number of Subjects With Solicited General Symptoms.** _(time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 2.)_ - **Number of Subjects With Solicited General Symptoms.** _(time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 3.)_ - **Number of Subjects With Solicited General Symptoms.** _(time frame: During the 4-day (Days 0-3) post-vaccination period following any dose.)_ - **Number of Subjects With Specific Adverse Events (AEs).** _(time frame: From Month 0 up to 6 months post primary-vaccination (Month 10))_ - **Number of Subjects With Unsolicited AEs.** _(time frame: During the 31-day (Days 0-30) post-primary vaccination period.)_ - **Number of Subjects With Serious Adverse Events (SAEs).** _(time frame: From Month 0 up to 6 months post-primary vaccination (Month 10))_ - **Number of Seroprotected Subjects Against Anti-T.** _(time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)])_ - **Number of Seroprotected Subjects Against Anti-D.** _(time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)])_ - **Antibody Concentrations for Anti-T.** _(time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)])_ - **Antibody Concentrations for Anti-D.** _(time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)])_ - **Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.** _(time frame: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)])_ - **Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN.** _(time frame: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)])_ - **Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN.** _(time frame: At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)])_ - **Number of Seroprotected Subjects Against Anti-PRP.** _(time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)])_ - **Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.** _(time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)])_ - **Antibody Concentrations for Anti-PRP.** _(time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)])_ - **Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.** _(time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)])_ - **Antibody Titres for Anti-polio Types 1, 2 and 3.** _(time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)])_ - **Number of Seroprotected Subjects Against Anti-HBs.** _(time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)])_ - **Antibody Concentrations for Anti-HBs.** _(time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)])_ - **Number of Subjects With Solicited Local Symptoms.** _(time frame: During the 4-day (Days 0-3) post-booster vaccination.)_ - **Number of Subjects With Solicited General Symptoms.** _(time frame: During the 4-day (Days 0-3) post-booster vaccination.)_ - **Number of Subjects With Specific AEs.** _(time frame: During the 31-day (Days 0-30) post-booster vaccination.)_ - **Number of Subjects With Unsolicited AEs.** _(time frame: During the 31-day (Days 0-30) post-booster vaccination.)_ - **Number of Subjects With SAEs.** _(time frame: During the 31-day (Days 0-30) post-booster vaccination.)_ ## Locations (43) - GSK Investigational Site, Tucson, Arizona, United States - GSK Investigational Site, Fayetteville, Arkansas, United States - GSK Investigational Site, Anaheim, California, United States - GSK Investigational Site, Daly City, California, United States - GSK Investigational Site, Fresno, California, United States - GSK Investigational Site, Hayward, California, United States - GSK Investigational Site, Oakland, California, United States - GSK Investigational Site, Pleasanton, California, United States - GSK Investigational Site, Roseville, California, United States - GSK Investigational Site, Sacramento, California, United States - GSK Investigational Site, Sacramento, California, United States - GSK Investigational Site, San Jose, California, United States - GSK Investigational Site, Santa Clara, California, United States - GSK Investigational Site, Walnut Creek, California, United States - GSK Investigational Site, Colorado Springs, Colorado, United States - GSK Investigational Site, Altamonte Springs, Florida, United States - GSK Investigational Site, Orange City, Florida, United States - GSK Investigational Site, Marietta, Georgia, United States - GSK Investigational Site, Woodstock, Georgia, United States - GSK Investigational Site, Nampa, Idaho, United States - GSK Investigational Site, Augusta, Kansas, United States - GSK Investigational Site, Newton, Kansas, United States - GSK Investigational Site, Topeka, Kansas, United States - GSK Investigational Site, Wichita, Kansas, United States - GSK Investigational Site, Louisville, Kentucky, United States - GSK Investigational Site, Louisville, Kentucky, United States - GSK Investigational Site, Nicholasville, Kentucky, United States - GSK Investigational Site, Columbia, Maryland, United States - GSK Investigational Site, Kansas City, Missouri, United States - GSK Investigational Site, Syracuse, New York, United States - GSK Investigational Site, Dayton, Ohio, United States - GSK Investigational Site, Erie, Pennsylvania, United States - GSK Investigational Site, Sellersville, Pennsylvania, United States - GSK Investigational Site, Kingsport, Tennessee, United States - GSK Investigational Site, Layton, Utah, United States - GSK Investigational Site, Payson, Utah, United States - GSK Investigational Site, Provo, Utah, United States - GSK Investigational Site, Salt Lake City, Utah, United States - GSK Investigational Site, South Jordan, Utah, United States - GSK Investigational Site, St. George, Utah, United States - GSK Investigational Site, West Jordan, Utah, United States - GSK Investigational Site, Charlottesville, Virginia, United States - GSK Investigational Site, Ellensburg, Washington, United States ## Recent Field Changes (last 30 days) - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.gsk investigational site|tucson|arizona|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|fayetteville|arkansas|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|anaheim|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|daly city|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|fresno|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|hayward|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|oakland|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|pleasanton|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|roseville|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|sacramento|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|san jose|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|santa clara|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|walnut creek|california|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|colorado springs|colorado|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|altamonte springs|florida|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|orange city|florida|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|marietta|georgia|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|woodstock|georgia|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|nampa|idaho|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|augusta|kansas|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|newton|kansas|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|topeka|kansas|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|wichita|kansas|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|louisville|kentucky|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|nicholasville|kentucky|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|columbia|maryland|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|kansas city|missouri|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|syracuse|new york|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|dayton|ohio|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|erie|pennsylvania|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|sellersville|pennsylvania|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|kingsport|tennessee|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|layton|utah|united states` — added _(2026-05-12)_ - `locations.gsk investigational site|payson|utah|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02096263.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02096263* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*