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This trial is complete. It is no longer accepting participants.

NCT00004800

NCT00004800
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

  • Newborns being enrolled at their first vaccine clinic visit
  • Baby girls who weigh between 3.2 and 3.8 kg at their first vaccination
  • Baby boys who weigh between 3.4 and 4.0 kg at their first vaccination
  • Babies who are older than 6 weeks but younger than 12 weeks of age
  • Babies who have never shown signs of whooping cough (pertussis)
  • Babies who have never received a whooping cough vaccine before
  • Babies whose mother speaks Italian and can be reached by phone
  • Babies whose family plans to stay in the local clinic area for at least 1 year

Who may not be able to join:

  • Babies who have previously been vaccinated against whooping cough
  • Babies who have had kidney (renal) failure
  • Babies who have received long-term medication that suppresses the immune system
  • Babies who have taken steroid medicines (corticosteroids) for 14 days or more, or who received them within the last 48 hours
  • Babies born with a major physical abnormality
  • Babies who are not growing or gaining weight as expected (sometimes called "failure to thrive")
  • Babies with a known or possible problem with their immune system — for example, if their mother is HIV-positive, or if the baby has certain blood or immune conditions (confirm with trial site)
  • Babies who have had brain or nervous system problems around the time of birth
  • Babies who have had seizures (convulsions)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Registry
clinicaltrials_gov
Start date
1 September 1992

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov