NCT01457508 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Crovari P
et al. Immunogenicity and reactogenicity of combined DTPa-HBV-IPV/Hib vaccine compared to concomitant administered DTPa-HBV-IPV and Hib vaccines given at 3, 5 and 11 months of age. Abstract presented at the 19th Annual Meeting ESPID, Istanbul, Turkey, 26-28 March 2001.
Gabutti G, Zepp F, Schuerman L, Dentico P, Bamfi F, Soncini R, Habermehl P, Knuf M, Crovari P; Cooperative Italian Group for the Study of Combined Vaccines
Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV Combination vaccine co-administered with a Hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age. Scand J Infect Dis. 2004;36(8):585-92.

Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vaccine Administered Separately

Details for clinical trial NCT01457508

Clinical trial NCT01457508 - References