---
title: Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
nct_id: NCT00617851
overall_status: COMPLETED
phase: PHASE3
sponsor: Novartis Vaccines
study_type: INTERVENTIONAL
primary_condition: Influenza
countries: Dominican Republic
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00617851.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00617851"
ct_last_update_post_date: 2012-05-08
last_seen_at: "2026-05-12T07:09:22.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old

**Official Title:** A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Consistency of Three Consecutive Lots of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs in Healthy Subjects Aged 18 to 49 Years

**NCT ID:** [NCT00617851](https://clinicaltrials.gov/study/NCT00617851)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1507
- **Lead Sponsor:** Novartis Vaccines
- **Conditions:** Influenza
- **Start Date:** 2007-11
- **Completion Date:** 2008-06
- **CT.gov Last Update:** 2012-05-08

## Brief Summary

The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 49 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* 18 to 49 years of age;
* In good health as determined by medical history and physical examination;
* Able and willing to provide written informed consent prior to any study procedure;
* Able to comply with all study procedures and available for all clinic visits scheduled in the study.

Exclusion Criteria:

* Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus
* History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex);
* Known or suspected impairment/alteration of immune function
* Receipt of an influenza vaccine within 6 months prior to Visit 1;
* Current drug or alcohol abuse or a history of drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
* Laboratory-confirmed influenza disease within 6 months prior to Visit 1
```

## Arms

- **Influenza virus vaccine (lot A)** (EXPERIMENTAL) — Lot A of the investigational influenza virus vaccine
- **Influenza virus vaccine (lot B)** (EXPERIMENTAL) — Lot B of the investigational influenza virus vaccine
- **Influenza virus vaccine (lot C)** (EXPERIMENTAL) — Lot C of the investigational influenza virus vaccine
- **Influenza virus vaccine (pooled)** (EXPERIMENTAL) — Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine
- **Comparator influenza vaccine** (ACTIVE_COMPARATOR) — A US licensed influenza virus vaccine

## Interventions

- **Lot A of Influenza virus vaccine** (BIOLOGICAL) — 1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly
- **Lot B of Influenza virus vaccine** (BIOLOGICAL) — 1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly
- **Lot C of Influenza virus vaccine** (BIOLOGICAL) — 1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly
- **Comparator influenza virus vaccine** (BIOLOGICAL) — 1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly
- **All 3 consecutive lots of influenza virus vaccine pooled** (BIOLOGICAL) — 1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly

## Primary Outcomes

- **Geometric Mean Titers (GMTs), by Vaccine Lots** _(time frame: 21 days after vaccination)_ — The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.

## Secondary Outcomes

- **Geometric Mean Titers (GMTs), by Vaccine Group and Strain** _(time frame: 21 days after vaccination)_
- **Number of Subjects Reporting Solicited Local and Systemic Symptoms** _(time frame: 7 days after vaccination)_
- **Number of Subjects With at Least One Unsolicited Adverse Event** _(time frame: 3 weeks after vaccination)_
- **Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)** _(time frame: 21 days after vaccination)_
- **Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)** _(time frame: 21 days after vaccination)_
- **Percentage of Subjects With Seroprotection and Seroconversion (Strain B)** _(time frame: 21 days after vaccination)_

## Locations (2)

- Centro de Salud Galvan, Santo Domingo, Dominican Republic
- Hosp. Nuestra Sra. Altagracia, Santo Domingo, Dominican Republic

## Recent Field Changes (last 30 days)

- `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)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — 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.centro de salud galvan|santo domingo||dominican republic` — added _(2026-05-12)_
- `locations.hosp. nuestra sra. altagracia|santo domingo||dominican republic` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00617851*  
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