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Completed

NCT Number: NCT01125527

Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children

This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 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

13 month–59 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

  • Infants 13-59 months of age.

Exclusion criteria

  • Prior Hib vaccine administration.
  • History of serious reaction(s) following vaccination.
  • Any vaccination within 7 days of study vaccination.
  • Known or suspected immune impairment.
  • Premature (before 37th week of gestation) or birth weight less than 2500g
  • For additional entry criteria please refer to the protocol.

Treatment and study plan

Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)

Biological

a single dose was administered

Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)

Biological

a single dose was administered

Primary outcomes

  1. Anti-PRP antibody levels at day 31 post last vaccination

    Time frame: 30 days after last vaccination

Secondary outcomes

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

    Time frame: 30 days post last vaccination

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
May 18, 2010
Registry last updated
Dec 1, 2016

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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