drugset / Trial / NCT00142389
Mother's Gift Project
Phase 1/2
Completed
680 enrolled
Johns Hopkins Bloomberg School of Public Health
Bill and Melinda Gates Foundation · collabInternational Centre for Diarrhoeal Disease Research, Bangladesh · collabThrasher Research Fund · collabUnited States Agency for International Development (USAID) · collabWyeth is now a wholly owned subsidiary of Pfizer · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant mothers, followed by pneumococcal conjugate immunization of their children is designed to assess the effects of these strategies on the immunogenicity and safety of both vaccines. We hypothesize that maternal followed by infant immunization will be safe and will provide higher levels of antibody from birth through 12 months of age.
Timeline
- Start
- 2004-08
- Primary completion
- —
- Completion
- 2006-12
Publications
- Schlaudecker EP, Steinhoff MC, Omer SB, McNeal MM, Roy E, Arifeen SE, Dodd CN, Raqib R, Breiman RF, Zaman K. IgA and neutralizing antibodies to influenza a virus in human milk: a randomized trial of antenatal influenza immunization. PLoS One. 2013 Aug 14;8(8):e70867. doi: 10.1371/journal.pone.0070867. eCollection 2013.
- Omer SB, Zaman K, Roy E, Arifeen SE, Raqib R, Noory L, Seib K, Breiman RF, Steinhoff MC. Combined effects of antenatal receipt of influenza vaccine by mothers and pneumococcal conjugate vaccine receipt by infants: results from a randomized, blinded, controlled trial. J Infect Dis. 2013 Apr;207(7):1144-7. doi: 10.1093/infdis/jit003. Epub 2013 Jan 8.
- Steinhoff MC, Omer SB, Roy E, El Arifeen S, Raqib R, Dodd C, Breiman RF, Zaman K. Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial. CMAJ. 2012 Apr 3;184(6):645-53. doi: 10.1503/cmaj.110754. Epub 2012 Feb 21.
- Zaman K, Roy E, Arifeen SE, Rahman M, Raqib R, Wilson E, Omer SB, Shahid NS, Breiman RF, Steinhoff MC. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med. 2008 Oct 9;359(15):1555-64. doi: 10.1056/NEJMoa0708630. Epub 2008 Sep 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 7-valent pneumococcal vaccine | Vaccine | — | — |
| Subject | Pneumovax 23 | Vaccine | — | — |