Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Population Aged 3 Years and Older

Summary

The primary safety objective of this study is to assess the safety of split- virion inactivated H1N1 vaccine with and without adjuvant when administered at the 7.5,15 or 30 mcg dose. The primary immunogenicity objective is to assess the antibody response following each dose of split- virion inactivated A(H1N1) vaccine with and without adjuvant. Participants will include up to 2200 healthy persons age 3 and older who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females, aged 3 years and older. Subjects will be stratified by elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years), elders and adolescents will be randomized into 5 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), children will be randomized into 4 dose groups (adjuvanted H1N1 vaccine of 7.5 or 15 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), adults will be randomized into 6 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose or placebo), 110 subjects per dose and age stratum will be to receive intramuscular influenza H1N1 vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. Following immunization, safety will be measured by assessment of adverse events through 21 days following the last vaccination (Day 42 for those receiving both doses), serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after second vaccination), and reactogenicity to the vaccine for 8 days (Day 0-7) following each vaccination. Immunogenicity testing will be hemagglutination inhibiting (HAI) on serum obtained on the day 21 of each vaccination (prior to vaccination), on Day 21 after first vaccination, and 21 days following the second vaccination (Day 42).

Conditions

• Virus Diseases
• Respiratory Tract Diseases
• Respiratory Tract Infections
• Influenza
• Orthomyxoviridae Infections

Interventions

BIOLOGICAL

split-virion, non-adjuvanted H1N1 vaccine of 30 μg

440 participants (110 elders, 110 adults, 110 adolescents and 110 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 30 μg on day 0 and 21.

BIOLOGICAL

Experimental: split-virion, adjuvanted H1N1 vaccine of 7.5 μg

440 participants (110 elders,110 adults, 110 adolescents and 110 children) to receive split-virion, adjuvanted H1N1 vaccine of 7.5 μg on day 0 and 21.

BIOLOGICAL

Experimental: split-virion, adjuvanted H1N1 vaccine of 15 μg

440 participants (110 elders, 110 adults, 110 adolescents and 110 children) to receive split-virion, adjuvanted H1N1 vaccine of 15 μg on day 0 and 21.

BIOLOGICAL

Experimental: split-virion, adjuvanted H1N1 vaccine of 30 μg

330 participants (110 elders, 110 adults, and 110 adolescents) to receive split-virion, adjuvanted H1N1 vaccine of 30 μg on day 0 and 21.

BIOLOGICAL

Experimental: split-virion, non-adjuvanted H1N1 vaccine of 15 μg

440 participants (110 elders, 110 adults, 110 adolescents and 110 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 15 μg on day 0 and 21.

BIOLOGICAL

Placebo Comparator: Placebo control

110 adults to receive placebo control (Phosphate Buffer Saline) on day 0 and 21.

Sponsors & Collaborators

• Hualan Biological Bacterin Co. Ltd.

  collaborator INDUSTRY

• Jiangsu Province Centers for Disease Control and Prevention

  lead NETWORK

Principal Investigators

• Feng-Cai Zhu, Master · Jiangsu CDPC

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-07-31

Primary Completion

2009-09-30

Completion

2010-02-28

Countries

• China

Study Locations