Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants
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|ClinicalTrials.gov Identifier: NCT00514709|
Recruitment Status : Completed
First Posted : August 10, 2007
Results First Posted : November 14, 2013
Last Update Posted : August 2, 2016
DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance.
- To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.
- To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth.
- To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).
|Condition or disease||Intervention/treatment||Phase|
|Diphtheria Tetanus Pertussis Hepatitis B Influenza||Biological: DTaP-HB PRP~T Combined Vaccine Biological: DTaP-HB-PRP~T vaccine Biological: Oral Polio Vaccine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1843 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine at 12 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants Having Received Hepatitis B Vaccine at Birth|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||April 2009|
Experimental: Group 1
DTaP-Hep B-PRP-T + OPV vaccine group
Biological: DTaP-HB PRP~T Combined Vaccine
0.5 mL, Intramuscular (IM)Biological: Oral Polio Vaccine
Oral co-administered with study vaccine.
Experimental: Group 2
Tritanrix-HepB/Hib™ + OPV vaccine group
Biological: DTaP-HB-PRP~T vaccine
0.5 mL, IMBiological: Oral Polio Vaccine
Oral co-administered with study vaccine.
- Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination ]
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.
Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response.
- Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination.
- Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) [ Time Frame: Day 0 up to Day 7 after vaccination ]
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.
Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.
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): NCT00514709
|Muntinlupa City, Alabang Junction Alabang, Philippines|
|Muntinlupa City, Alabang, Philippines|
|Muntinlupa City, Bayanan Annex, Philippines|
|Muntinlupa City, Cupang, Philippines|
|Muntinlupa City, Filinvest, Philippines|
|Muntinlupa City, Putatan, Philippines|
|Muntinlupa City, Tunasan, Philippines|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|