Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec · 1 trial · 5 indications
| Name | Type | Description |
|---|---|---|
| Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec | BIOLOGICAL | - |
Inclusion Criteria: * Healthy male or female infant between, \& including, 0 \& 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 \& 42 weeks). * Written informed consent obtained from the parent/guardian of the subject. Exclusion Criteria: * Use of any ...
It is a Phase 3 vaccine study regimen developed by GSK plc (ticker GSK). The trial evaluated combined and separate vaccine schedules against common diseases in infants, including poliomyelitis, tetanus, acellular pertussis, hepatitis B, and diphtheria. It enrolled 480 infants in Spain and has been completed.
GSK plc, which trades under the ticker GSK, is the developer of this vaccine study regimen. The trial was sponsored by GSK and conducted in Spain. The study compared combined and separate vaccine schedules in infants.
The study is in Phase 3. It has been completed, with 480 infants enrolled. The trial was randomized but not double-blind, and it was conducted in Spain. It evaluated vaccine schedules against poliomyelitis and other common diseases in infants.
The Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec was evaluated in one clinical trial, NCT00352963, titled Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). The trial is completed and enrolled 480 infants in Spain.