Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents

Summary

The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).

Timeline

Start

2007-10

Primary completion

2008-02

Completion

2008-07

Outcome

Mixed primary results

paper both CCIV and TIV met all 3 Committee for Medicinal Products for Human Use immunogenicity criteria for A/H1N1 and A/H3N2 strains. PMID 22301476 ↗

paper Lower immune responses were observed against the B strain, fulfilling Committee for Medicinal Products for Human Use criteria only for geometric mean ratio (TIV, CCIV) PMID 22301476 ↗

paper and seroconversion rate (TIV, CCIV [cell-derived antigen]). PMID 22301476 ↗

Publications

• Results Vesikari T, Block SL, Guerra F, Lattanzi M, Holmes S, Izu A, Gaitatzis N, Hilbert AK, Groth N. Immunogenicity, safety and reactogenicity of a mammalian cell-culture-derived influenza vaccine in healthy children and adolescents three to seventeen years of age. Pediatr Infect Dis J. 2012 May;31(5):494-500. doi: 10.1097/INF.0b013e31824bb179.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Optaflu	Vaccine	0.5 ml	Intramuscular
Comparator	TIV	Vaccine	0.5 ml	Intramuscular

Indications