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A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy Europeans Children Aged 6 to 35 Months

NCT00956046 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2014-01-14

No results posted yet for this study

Summary

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.

Primary objectives:

* To describe the immune response to vaccines 21 days after each vaccination in all participants.
* To describe the antibody persistence eight months after the first vaccine administration using hemagglutination inhibition (HAI) method in a subset of participants who received two half-doses of either formulation 1 or 2.
* To describe the immune response against the A/H1N1 strain using the HAI method 21 days after last vaccination with the 2010-2011 NH seasonal Trivalent Influenza Vaccine (TIV) administered 13 months after the first vaccination in a subset of subjects who received two half-doses of either t either formulation 1 or 2 of the A/H1N1 influenza vaccines as primary series.
* To describe the safety profile of each vaccine in all participants.

Conditions

Interventions

BIOLOGICAL

Swine A/H1N1 influenza vaccine (split virion, inactivated)

0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).

BIOLOGICAL

Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)

0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)

BIOLOGICAL

Swine A/H1N1 influenza vaccine (split virion, inactivated + adjuvant)

0.5 mL, Intramuscular on Day 0 and Day 21

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-01-31
Completion
2011-06-30

Countries

  • Finland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00956046 on ClinicalTrials.gov