At a glance
ClinicalIndex Comparison Record- ✓Male or female infants 8-16 weeks (56-118 days) of age at first vaccination
- ✓Gestation period >27 weeks (at least 189 days)
- ✓If full term, healthy as established by medical history and clinical examination
- ✓If premature, medically stable (not requiring significant medical support or ongoing management for debilitating disease with sustained recovery)
- ✕Use of any investigational or non-registered product within 30 days before first dose
- ✕Chronic immunosuppressant or immune-modifying drug use (>14 days) from birth to first vaccine dose
- ✕Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis, or Streptococcus pneumoniae (except vaccines given within first two weeks of life per national recommendations)
- ✕History of diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b, Neisseria meningitidis, or Streptococcus pneumoniae disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study to Assess the Safety and Immunogenicity of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine When Co-administered With DTPa-HBV-IPV/Hib (Infanrix-Hexa) Vaccine in Preterm Infants as a 3-dose Primary Immunization Course During the First 6 Months of Life.
In Brief
A Phase 3 clinical trial evaluating Pneumococcal conjugate vaccine GSK1024850A and Infanrix hexa for Infections, Streptococcal. Completed, enrolled 286 participants across 8 sites in 2 countries.
Detailed Summary
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life. This protocol posting deals with objectives \& outcome measures of the primary study. The objectives \& outcome measures of the Booster study are presented in a separate protocol posting (NCT number = 00609492)
Study Details
Timeline
Interventions
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses