Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
Public ClinicalTrials.gov record NCT03621670. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccinesv(RIV).
Study identification
- NCT ID
- NCT03621670
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,196 participants
Conditions and interventions
Conditions
Interventions
- Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ) Biological
- Prevnar13 Biological
- Pediarix Biological
- Hiberix Biological
- Rotarix Biological
- M-M-R II Biological
- Varivax Biological
- Placebo (saline water) Biological
- Prevnar 20 Biological
Biological
Eligibility (public fields only)
- Age range
- 6 Weeks to 12 Weeks
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 27, 2018 (Actual)
- Primary completion
- Dec 27, 2024 (Actual)
- Completion
- Dec 27, 2024 (Actual)
- Last update posted
- Aug 20, 2026
2018 – 2024
United States locations
- U.S. sites
- 56
- U.S. states
- 24
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35205 | — |
| GSK Investigational Site | Fayetteville | Arkansas | 72703 | — |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | — |
| GSK Investigational Site | Anaheim | California | 92804 | — |
| GSK Investigational Site | Oakland | California | 94611 | — |
| GSK Investigational Site | Roseville | California | 95661 | — |
| GSK Investigational Site | Walnut Creek | California | 94596 | — |
| GSK Investigational Site | West Covina | California | 91790 | — |
| GSK Investigational Site | Lake Mary | Florida | 32746 | — |
| GSK Investigational Site | Miami | Florida | 33142 | — |
| GSK Investigational Site | Tampa | Florida | 33613 | — |
| GSK Investigational Site | Nampa | Idaho | 83686 | — |
| GSK Investigational Site | Nampa | Idaho | 83702 | — |
| GSK Investigational Site | Newton | Kansas | 67114 | — |
| GSK Investigational Site | Topeka | Kansas | 66604 | — |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | — |
| GSK Investigational Site | Louisville | Kentucky | 40202 | — |
| GSK Investigational Site | Louisville | Kentucky | 40207 | — |
| GSK Investigational Site | Louisville | Kentucky | 40291 | — |
| GSK Investigational Site | Baltimore | Maryland | 21021 | — |
| GSK Investigational Site | Fall River | Massachusetts | 02721 | — |
| GSK Investigational Site | Bingham Farms | Michigan | 48025 | — |
| GSK Investigational Site | Kansas City | Missouri | 64108 | — |
| GSK Investigational Site | Lincoln | Nebraska | 68516 | — |
| GSK Investigational Site | Omaha | Nebraska | 68128 | — |
| GSK Investigational Site | Liverpool | New York | 13090 | — |
| GSK Investigational Site | Syracuse | New York | 13210 | — |
| GSK Investigational Site | Boone | North Carolina | 28607 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45245 | — |
| GSK Investigational Site | Dayton | Ohio | 45406 | — |
| GSK Investigational Site | Dayton | Ohio | 45414 | — |
| GSK Investigational Site | Fairfield | Ohio | 45014 | — |
| GSK Investigational Site | South Euclid | Ohio | 44121 | — |
| GSK Investigational Site | Hermitage | Pennsylvania | 16148 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15224 | — |
| GSK Investigational Site | Charleston | South Carolina | 29406 | — |
| GSK Investigational Site | Sioux Falls | South Dakota | 57105 | — |
| GSK Investigational Site | Clarksville | Tennessee | 37040 | — |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | — |
| GSK Investigational Site | Beaumont | Texas | 77706 | — |
| GSK Investigational Site | Bryan | Texas | 77802 | — |
| GSK Investigational Site | Edinburg | Texas | 78504 | — |
| GSK Investigational Site | Houston | Texas | 77065 | — |
| GSK Investigational Site | Houston | Texas | 77090 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | San Antonio | Texas | 78244 | — |
| GSK Investigational Site | Layton | Utah | 84041 | — |
| GSK Investigational Site | Orem | Utah | 84057 | — |
| GSK Investigational Site | Provo | Utah | 84604 | — |
| GSK Investigational Site | Roy | Utah | 84067 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84121 | — |
| GSK Investigational Site | Syracuse | Utah | 84075 | — |
| GSK Investigational Site | Richmond | Virginia | 23298 | — |
| GSK Investigational Site | Spokane | Washington | 99202 | — |
| GSK Investigational Site | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03621670, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2026 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03621670 live on ClinicalTrials.gov.