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Infanrix-IPV+Hib and Prevenar · 1 trial · 5 indications
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | PEDIACEL co-administered with Prevenar |
| Group 2 | ACTIVE_COMPARATOR | Infanrix-IPV+Hib co-administered with Prevenar |
| Name | Type | Description |
|---|---|---|
| PEDIACEL® and Prevenar® | BIOLOGICAL | 0.5 mL each, IM (opposite thigh) |
| Infanrix®-IPV+Hib and Prevenar® | BIOLOGICAL | 0.5 mL each, IM (opposite thigh) |
Inclusion Criteria: * Infants 55 to 75 days old, inclusive on the day of first vaccination * Born at full term of pregnancy (\> 37 weeks) * Informed consent form signed by the parent(s) or the legal guardian * Parents or the legal guardian able to read and write in the local language * Parent(s) or...
Infanrix-IPV+Hib and Prevenar refers to a combination vaccine regimen studied together in infants and toddlers. Infanrix-IPV+Hib is a diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b vaccine, while Prevenar is a pneumococcal conjugate vaccine. The two were co-administered in a Phase 3 study.
The combination is used for immunization against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b, with Prevenar covering pneumococcal disease. The Phase 3 study enrolled healthy infants and toddlers and listed diphtheria among the target conditions. Both products are given together as part of routine pediatric vaccination schedules.
Sanofi develops Infanrix-IPV+Hib, and the company is listed under the ticker SNY. The Phase 3 study NCT00343421 compared Pediacel to Infanrix-IPV+Hib when both were co-administered with Prevenar in infants and toddlers. Sanofi is the developer associated with the Infanrix-IPV+Hib component of this regimen.
The co-administration of Infanrix-IPV+Hib with Prevenar has been studied in a Phase 3 trial. That study, NCT00343421, is completed. The trial was randomized, active controlled, and enrolled 588 participants across France and Poland. It was not double blinded and did not use biomarker selection.
One Phase 3 trial, NCT00343421, studied Infanrix-IPV+Hib co-administered with Prevenar. Titled a study to compare Pediacel to Infanrix-IPV+Hib when both are co-administered with Prevenar in infants and toddlers, it enrolled 588 healthy volunteers aged 55 days and older, with all sexes eligible, and it is completed.