At a glance
ClinicalIndex Comparison Record- ✓Male or female infant between 8 and 16 weeks of age (56-120 days) at first vaccination
- ✓Born after gestation period of 36 to 42 weeks
- ✓Free of obvious health problems by medical history and clinical examination before study entry
- ✓Parents/guardians can and will comply with protocol requirements
- ✕Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae
- ✕History of diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, and/or invasive pneumococcal diseases
- ✕History of allergic disease or reactions likely to be exacerbated by any vaccine component
- ✕History of neurologic disorders or seizures
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open, Randomized, Phase IIIa Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered Intramuscularly According to a 2-4-11 Months Vaccination Schedule
In Brief
A Phase 3 clinical trial evaluating GSK Biologicals' 10-valent pneumococcal conjugate vaccine., Infanrix hexa., and 1 other intervention for Infections, Streptococcal. Completed, enrolled 351 participants across 8 sites in 4 countries.
Detailed Summary
Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of age) and after the complete 2, 4, 11 months schedule when co-administered with DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)
Study Details
Timeline
Interventions
Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).
Intramuscular injection, 3 doses (2-4-11 months of age schedule).
Intramuscular injection, 3 doses (2-4-11 months of age schedule).