Assessing a new rotavirus vaccine for infants in Africa and India
A Phase 3 Double-blind, Randomized, Active Comparator-controlled, Group-sequential, Multinational Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants
This study is testing a new rotavirus vaccine for healthy infants in Africa and India to see if it can better prevent severe stomach infections compared to the current vaccine.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 8200 (estimated) |
| Ages | 6 Weeks to 8 Weeks |
| Sex | All |
| Sponsor | Path Academic / other |
| Locations | 1 site (Lusaka) |
| Trial ID | NCT04010448 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety, immunogenicity, and efficacy of a trivalent rotavirus P2-VP8 subunit vaccine in preventing severe rotavirus gastroenteritis in healthy infants. It is a multinational, randomized, double-blind study where infants will receive either the new vaccine or the existing Rotarix vaccine. Participants will be monitored for episodes of gastroenteritis and adverse events throughout the study period. The trial aims to provide insights into the vaccine's effectiveness in diverse populations.
Who should consider this trial
Good fit: Ideal candidates are healthy infants aged between 6 to 8 weeks at the time of the first vaccination.
Not a fit: Patients with acute diseases or severe malnutrition at the time of vaccination may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could significantly reduce the incidence of severe rotavirus gastroenteritis in infants, improving child health outcomes.
How similar studies have performed: Other studies have shown success with similar vaccine approaches, indicating potential for this new vaccine to be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy infants as established by medical history and clinical examination before entering the study * Age: ≥6 and \<8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day old) * Parental/legal guardian's ability and willingness to provide written informed consent * Intention of the participants' parents to remain in the area with the child during the study period Exclusion Criteria: * Acute disease at the time of first study vaccination - temporary exclusion * Presence of fever on the day of first study vaccination (axillary temperature \>37.6oC) - temporary exclusion * Concurrent participation in another clinical trial throughout the entire timeframe for this study (participation in non-interventional observational study is allowed if there is no blood draw) * Presence of severe malnutrition (weight-for-height z-score ≤-3SD median, per WHO published child growth standards) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination that would compromise the participant's health or is likely to result in nonconformance to the protocol * History of premature birth (\<37 weeks gestation) and/or birth weight of \<2.5 kg * History of congenital abdominal disorders, intussusception, or abdominal surgery * Prior receipt of rotavirus vaccine * Known sensitivity or allergy to any components of the study vaccine * Contraindication to any EPI/UIP vaccine * History of anaphylactic reaction * Major congenital or genetic defect * Parents not able, available or willing to accept active weekly follow-up by the study staff * Receipt of any immunoglobulin therapy and/or blood products * Nursing infants whose mother are receiving immunosuppressive biologicals * History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (those on inhaled or topical steroids may be permitted to participate in the study) * Any medical condition in the participant or parents that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a parents' ability to give informed consent
Where this trial is running
Lusaka
- Centre for Infectious Disease Research in Zambia (CIDRZ) — Lusaka, Zambia (Recruiting)
Study contacts
- Principal investigator: George Armah, PhD — Noguchi Memorial Institute for Medical Research, University of Ghana, Legon
- Study coordinator: Joanne Csedrik, RN, MPH
- Email: jcsedrik@path.org
- Phone: +1-202-540-4496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.