---
title: A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age
nct_id: NCT00848887
overall_status: COMPLETED
phase: PHASE1
sponsor: Novartis
study_type: INTERVENTIONAL
primary_condition: Influenza
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00848887.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00848887"
ct_last_update_post_date: 2014-01-24
last_seen_at: "2026-05-12T06:38:35.894Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age

**Official Title:** A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine With or Without a Second Influenza B Strain in Combination With or Without One of Three Different Doses of Adjuvant in Healthy Children, Aged 6 to <36 Months

**NCT ID:** [NCT00848887](https://clinicaltrials.gov/study/NCT00848887)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 410
- **Lead Sponsor:** Novartis
- **Collaborators:** Novartis Vaccines
- **Conditions:** Influenza
- **Start Date:** 2008-10
- **Completion Date:** 2009-05
- **CT.gov Last Update:** 2014-01-24

## Brief Summary

This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.

## Eligibility

- **Minimum age:** 6 Months
- **Maximum age:** 35 Months
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Children of 6 month to \<36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator.

Exclusion Criteria:

* History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected impairment/alteration of immune function.
```

## Arms

- **1** (EXPERIMENTAL)

## Interventions

- **Adjuvanted and un-adjuvanted influenza vaccines** (BIOLOGICAL) — 16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.

## Primary Outcomes

- **Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.** _(time frame: 50 days)_

## Secondary Outcomes

- **Strain-specific influenza antibody titers will be used to assess Immunogenicity** _(time frame: 50 days)_

## Locations (1)

- UCL St. Luc - Pharmacy, Brussels, Belgium

## Recent Field Changes (last 30 days)

- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — 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)_
- `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)_
- `locations.ucl st. luc - pharmacy|brussels||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00848887.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00848887*  
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