Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
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| ClinicalTrials.gov Identifier: NCT00534833 |
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Recruitment Status :
Completed
First Posted : September 26, 2007
Results First Posted : November 21, 2013
Last Update Posted : November 21, 2013
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The present trial is a follow-up of AL203 study (NCT00343889).
Primary Objectives:
To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine [OPV]).
Secondary Objective:
To describe the safety profile of a booster dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Influenzae Type b | Biological: DTaP-HB-PRP~T vaccine Biological: Tritanrix-HepB/Hib™ Biological: Oral Polio Vaccine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 362 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine or Tritanrix HepB/Hib™ at 15 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants |
| Study Start Date : | September 2007 |
| Actual Primary Completion Date : | September 2008 |
| Actual Study Completion Date : | March 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1
DTaP-Hep B-PRP-T + OPV vaccine group
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Biological: DTaP-HB-PRP~T vaccine
0.5 mL, Intramuscular Biological: Oral Polio Vaccine 0.5 mL, Oral |
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Active Comparator: Group 2
Tritanrix-HepB/Hib™ + OPV vaccine group
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Biological: Tritanrix-HepB/Hib™
0.5 mL, Intramuscular Biological: Oral Polio Vaccine 0.5 mL, Oral |
- Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: 28 Days post-vaccination ]
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization 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 at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio.
- Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: Day 28 post-vaccination ]Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination
- Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: Day 0 up to Day 7 post-vaccination ]
Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.
Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - 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.
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| Ages Eligible for Study: | 15 Months to 18 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive)
- Participated in the AL203 study and completed the three-dose primary series with either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age
- Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
- Able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria:
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received in the last 3 months
- Any vaccination in the 4 weeks preceding the trial vaccination
- Vaccination planned in the 4 weeks following the trial vaccination
- Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion
- History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically)
- Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B, or poliovirus 3 types antigen since the end of the primary series
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
- Serious adverse event related to any vaccination in the AL203 study.
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): NCT00534833
| Philippines | |
| Manila, Philippines | |
| Quezon City, Philippines | |
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT00534833 |
| Other Study ID Numbers: |
AL205 |
| First Posted: | September 26, 2007 Key Record Dates |
| Results First Posted: | November 21, 2013 |
| Last Update Posted: | November 21, 2013 |
| Last Verified: | September 2013 |
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Diphtheria Tetanus Pertussis Hepatitis B Hansenula (HB) Haemophilus influenzae type b |
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Whooping Cough Tetanus Diphtheria Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Hepadnaviridae Infections |
DNA Virus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Infection Clostridium Infections Gram-Positive Bacterial Infections Corynebacterium Infections Actinomycetales Infections Vaccines Immunologic Factors Physiological Effects of Drugs |