drugset / Trial / NCT00617682
Maternal Immunization To Prevent Infant Otitis Media
Phase 1/2
Completed
153 enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The main objective of this study is to evaluate whether immunization with 9-valent pneumococcal conjugate vaccine (PNCRM9) during the third trimester of pregnancy interferes with active antibody production in offspring immunized with PNCRM7 (Prevnar) in the first six months of life.
Timeline
- Start
- 2000-10
- Primary completion
- 2004-12
- Completion
- 2004-12
Publications
- Background Le CT, Grambsch PM, Giebink GS. Quality control and the identification of vaccine responders using ELISA-derived antibody data. Stat Med. 2003 Sep 30;22(18):2935-42. doi: 10.1002/sim.1530.
- Background Daly KA, Toth JA, Giebink GS. Pneumococcal conjugate vaccines as maternal and infant immunogens: challenges of maternal recruitment. Vaccine. 2003 Jul 28;21(24):3473-8. doi: 10.1016/s0264-410x(03)00354-2.
- Daly KA, Scott Giebink G, Lindgren BR, Knox J, Haggerty BJ, Nordin J, Goetz S, Ferrieri P. Maternal immunization with pneumococcal 9-valent conjugate vaccine and early infant otitis media. Vaccine. 2014 Dec 5;32(51):6948-6955. doi: 10.1016/j.vaccine.2014.10.060. Epub 2014 Oct 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | PNCRM9 | Vaccine | 0.5 ml | Intramuscular |