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The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:
- One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) - GSK Biologicals' Tritanrix™-HepB/Hiberix™
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hib-MenAC Lot 1 Group | Experimental | Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 1 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh. |
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| Hib-MenAC Lot 2 Group | Experimental | Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 2 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh. |
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| Hib-MenAC Lot 3 Group | Experimental | Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 3 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh. |
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| Hiberix Group | Active Comparator | Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB vaccine mixed extemporaneously with conjugate vaccine Hiberix at 2, 4 and 6 months of age as intramuscular injection in the anterolateral part of the thigh. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tritanrix-HepB/Meningitec conjugate vaccine | Biological | The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1 | Days 0-3 post dose 1 | |
| Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2 | Days 0-3 post dose 2 | |
| Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3 | Days 0-3 post dose 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose | Days 0-3 after each dose | |
| Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose | Day 0-30 after each dose |
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Inclusion criteria at study entry:
Exclusion criteria at study entry:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | City of Muntinlupa | 1781 | Philippines |
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| Tritanrix/Hiberix vaccine | Biological | The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection. |
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| Occurrence of serious adverse events during the entire study period | Day 0 up to Month 5 |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D006509 | Hepatitis B |
| D006192 | Haemophilus Infections |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D003015 | Clostridium Infections |
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