Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
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|ClinicalTrials.gov Identifier: NCT00880477|
Recruitment Status : Completed
First Posted : April 13, 2009
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B||Biological: DTPa-HBV-IPV/Hib vaccine Biological: DTPa-IPV/Hib vaccine Biological: EngerixTM-B||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of GSK Biological's DTPa-HBV-IPV/Hib Vaccine or DTPa-IPV/Hib Co-administered With HBV Vaccine as Primary and Booster Vaccination in Healthy Infants Born to Hepatitis B Surface Antigen Negative Mothers|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||November 2002|
|Actual Study Completion Date :||November 2002|
|Experimental: Group A||
Biological: DTPa-HBV-IPV/Hib vaccine
Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.
|Experimental: Group B||
Biological: DTPa-IPV/Hib vaccine
Vaccination according to a 3-dose schedule at at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.
The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age.
- Seroprotective anti-HBs antibody titres above protocol specified cut-off value [ Time Frame: At the time of the second dose of combined vaccination, one month after the 3rd dose of combined vaccination and one month after the booster dose. ]
- Antibody titres against all investigational vaccine antigen components [ Time Frame: One month after first combined vaccine dose, two months after Dose 1, one month after third combined vaccine dose prior to booster vaccination and one month post-booster vaccination. ]
- Occurrence of solicited symptoms [ Time Frame: During the 4-day follow-up period after each dose ]
- Occurrence of unsolicited symptoms [ Time Frame: During the 30-day follow-up period after each dose of study vaccine ]
- Occurrence of Serious Adverse Events [ Time Frame: From the birth dose of hepatitis B vaccine and ending with the last study visit or performance of the last study procedure or a minimum of 30 days following the third dose of the mixed vaccines and from the start of booster dose and ending a minimum of 3 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880477
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|