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NCT Number: NCT01025544

Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China

This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.

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Key information

Conditions

Haemophilus Influenzae Type b (Hib) Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Haemophilus Infections Infections Pasteurellaceae Infections

Age range

12 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hebei Province, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Toddlers 12-18 months of age who have previously participated in study M37P2.

Exclusion criteria

  • Prior Hib booster administration.
  • History of serious reaction(s) following vaccination.
  • Vaccination within 14 days of study vaccination.
  • Known or suspected immune impairment.
  • For additional entry criteria please refer to the protocol.

Treatment and study plan

Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)

Biological

Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.

Hiberix (Haemophilus influenzae type b (Hib) vaccine)

Biological

Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.

Primary outcomes

  1. Anti-PRP antibody levels at day 31 post booster

    Time frame: 31 days after vaccination

Secondary outcomes

  1. Solicited local and systemic reactions, AEs, and SAEs

    Time frame: 30 days post vaccination

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase III Open Label, Multi-Center Pediatric Study in China Comparing Booster Doses of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b (Hib) Infection

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Dec 3, 2009
Registry last updated
Dec 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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