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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-503070-36-00 | Registry Identifier | CTIS (EU) |
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BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
This study is seeking healthy pregnant participants:
A subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and/or pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and/or toddler (booster) doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GBS6 | Experimental | Multivalent group B streptococcus vaccine |
|
| Placebo | Placebo Comparator | Placebo |
|
| Infanrix hexa | Experimental | Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib) |
|
| Prevenar 20 | Experimental | Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae |
|
| Pediarix | Experimental | Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio |
|
| Prevnar 20 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivalent Group B streptococcus vaccine | Biological | Multivalent Group B streptococcus vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention | Within 7 days | |
| The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention | Within 7 days | |
| The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention | 1 month | |
| The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery | 6 months after delivery | |
| The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery | 6 months after delivery | |
| The proportion of maternal participants reporting adverse events of special interest (AESIs) through 6 months after delivery. | 6 months after delivery | |
| The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events (AEs) from birth through 1 month of age | Birth to 1 month of age | |
| The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting serious adverse events (SAEs) from birth through end of the study | Through study completion, at least 1 year | |
| Measure | Description | Time Frame |
|---|---|---|
| To measure GBS serotype-specific opsonophagocytic titers in infant participants at birth by geometric mean ratio between GBS6 group versus placebo group and by the difference in seroresponse rates between GBS6 group and placebo group | Birth | |
| To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS disease (all disease) caused by the 6 individual vaccine serotypes in infants when GBS6 is administered to healthy pregnant women. |
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Key Inclusion criteria- Maternal:
Key Exclusion criteria- Maternal:
Key Inclusion criteria- Infant Participants
- Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian
Key Exclusion Criteria - Infant Participants:
- Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.
Key Exclusion Criteria - Infant immunogenicity subset Participants:
- Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset.
Refer to the study contact for further eligibility details
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Research in Women's Health | Recruiting | Birmingham | Alabama | 35233 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
|
| Infanrix | Experimental | Commercially available combination vaccine containing diphtheria, tetanus, and pertussis |
|
| Placebo | Biological | Saline Control |
|
| Infanrix hexa | Biological | Vaccine administered in a subset of infant participants as per the national immunization schedule |
|
| Prevenar 20 | Biological | Vaccine administered in a subset of infant participants as per the national immunization schedule |
|
| Pediarix | Biological | Vaccine administered in a subset of infant participants as per the national immunization schedule |
|
| Prevnar 20 | Biological | Vaccine administered in a subset of infant participants as per the national immunization schedule |
|
| Infanrix | Biological | Vaccine administered in a subset of infant participants as per the national immunization schedule |
|
| The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting medically attended adverse events (MAAEs) from birth through 6 months of age |
| Birth to 6 months of age |
| The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events of special interest (AESIs) from birth through end of study | Through study completion, at least 1 year |
| To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS late onset disease thresholds in the GBS6 group to the placebo group | Birth |
| To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS early onset disease thresholds in the GBS6 group to the placebo group | Birth |
| To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS late onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth. | Birth |
| To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS early onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth. | Birth |
| Birth |
| To describe anti-CPS IgG antibody levels in infant participants born to maternal participants vaccinated with GBS6. | Birth |
| To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS LOD and EOD, separately, caused by the 6 individual vaccine serotypes (Ia, Ib, II, III, IV, and V) in infants when GBS6 is administered to healthy pregnant women. | Birth |
| To measure GBS serotype-specific IgG by geometric mean concentration in maternal participants at 1 month after vaccination and at delivery. | 1 month after vaccination and at delivery |
| Compare the proportion of infants with anti-diphtheria toxoid and/or pneumococcal IgG responses at 1 month post-primary and toddler doses between GBS6 and placebo groups, including predefined IgG levels and geometric mean ratios. | 1 month after the primary vaccination series and 1 month after the toddler dose |
| Children's of Alabama |
| Recruiting |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| University of Alabama at Birmingham - School of Medicine | Recruiting | Birmingham | Alabama | 35233 | United States |
| University of Alabama at Birmingham Women & Infants Center | Recruiting | Birmingham | Alabama | 35294 | United States |
| SEC Clinical Research | Recruiting | Dothan | Alabama | 36305 | United States |
| USA Health Allen Cox Building | Recruiting | Mobile | Alabama | 36604 | United States |
| USA Health Children's and Women's Hospital | Recruiting | Mobile | Alabama | 36604 | United States |
| USA Health Mitchell Cancer Institute | Recruiting | Mobile | Alabama | 36604 | United States |
| USA Health Strada Patient Care Center | Recruiting | Mobile | Alabama | 36604 | United States |
| ClinMed | Recruiting | Phoenix | Arizona | 85004 | United States |
| Valleywise Comprehensive Health Center Women's Clinic | Recruiting | Phoenix | Arizona | 85008 | United States |
| Valleywise Health Medical Center | Recruiting | Phoenix | Arizona | 85008 | United States |
| Genesis OB/GYN | Recruiting | Tucson | Arizona | 85741 | United States |
| Eclipse Clinical Research | Recruiting | Tucson | Arizona | 85745 | United States |
| Antelope Valley Medical Center | Recruiting | Lancaster | California | 93534 | United States |
| Chemidox Clinical Trials | Recruiting | Lancaster | California | 93534 | United States |
| Loma Linda University Children's Hospital | Recruiting | Loma Linda | California | 92354 | United States |
| Loma Linda University Health System | Recruiting | Loma Linda | California | 92354 | United States |
| Loma Linda University Pediatrics Clinic | Recruiting | Loma Linda | California | 92354 | United States |
| Lucile Packard Children's Hospital | Recruiting | Palo Alto | California | 94304 | United States |
| Stanford Obstetrics Clinic | Recruiting | Palo Alto | California | 94304 | United States |
| Stanford University Medical Center | Recruiting | Palo Alto | California | 94304 | United States |
| Stanford University | Recruiting | Palo Alto | California | 94304 | United States |
| Anschutz Health Sciences Building | Recruiting | Aurora | Colorado | 80045 | United States |
| Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
| CU Research Pharmacy | Recruiting | Aurora | Colorado | 80045 | United States |
| University of Colorado AO1 | Recruiting | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital Outpatient Pavilion | Recruiting | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital | Recruiting | Aurora | Colorado | 80045 | United States |
| University of Colorado Research II Building | Recruiting | Aurora | Colorado | 80045 | United States |
| South Florida Clinical Research Institute - Margate | Recruiting | Margate | Florida | 33063 | United States |
| Citadelle Clinical Research | Recruiting | North Miami Beach | Florida | 33162 | United States |
| Emerald Coast OBGYN Clinical Research | Recruiting | Panama City | Florida | 32405 | United States |
| HCA Florida Gulf Coast Hospital | Recruiting | Panama City | Florida | 32405 | United States |
| Advanced Specialty Research | Recruiting | Boise | Idaho | 83702 | United States |
| Express Lab | Recruiting | Garden City | Idaho | 83714 | United States |
| Clinical Research Prime | Recruiting | Idaho Falls | Idaho | 83404 | United States |
| Eastern Idaho Regional Medical Center | Recruiting | Idaho Falls | Idaho | 83404 | United States |
| Mountain View Hospital | Recruiting | Idaho Falls | Idaho | 83404 | United States |
| Madison Memorial Hospital | Recruiting | Rexburg | Idaho | 83440 | United States |
| Accellacare - McFarland | Recruiting | Ames | Iowa | 50010 | United States |
| Mary Greeley Medical Center | Recruiting | Ames | Iowa | 50010 | United States |
| McFarland Clinic, PC | Recruiting | Ames | Iowa | 50010 | United States |
| Velocity Clinical Research, Covington | Recruiting | Covington | Louisiana | 70433 | United States |
| Ochsner Baptist Medical Center | Recruiting | New Orleans | Louisiana | 70115 | United States |
| Center for Immunization Research | Recruiting | Baltimore | Maryland | 21205 | United States |
| Center for Immunization Research | Recruiting | Baltimore | Maryland | 21224 | United States |
| Johns Hopkins Bayview Medical Center | Recruiting | Baltimore | Maryland | 21224 | United States |
| Gynecology and Obstetrics at Johns Hopkins Health Care and Surgery Center- White Marsh | Recruiting | Nottingham | Maryland | 21236 | United States |
| Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| Boeson Research GTF | Recruiting | Great Falls | Montana | 59405 | United States |
| Great Falls OBGYN Associates | Recruiting | Great Falls | Montana | 59405 | United States |
| Origin Health GTF | Recruiting | Great Falls | Montana | 59405 | United States |
| Blue Moose Pediatrics | Recruiting | Missoula | Montana | 59804 | United States |
| Boeson Research MSO | Recruiting | Missoula | Montana | 59804 | United States |
| Origin Health | Recruiting | Missoula | Montana | 59804 | United States |
| CHI Health St Francis | Recruiting | Grand Island | Nebraska | 68803 | United States |
| Grand Island Regional Medical Center | Recruiting | Grand Island | Nebraska | 68803 | United States |
| Velocity Clinical Research, Grand Island | Recruiting | Grand Island | Nebraska | 68803 | United States |
| Midwest Children's Health Research Center | Recruiting | Lincoln | Nebraska | 68504 | United States |
| Midwest Children's Health Research Center | Recruiting | Lincoln | Nebraska | 68505 | United States |
| Bryan Health | Recruiting | Lincoln | Nebraska | 68506 | United States |
| Midwest Children's Health Research Institute | Recruiting | Lincoln | Nebraska | 68516 | United States |
| Women's Health Care Center of Williamsburg | Recruiting | Lincoln | Nebraska | 68516 | United States |
| Midwest Children's Health Research Center | Recruiting | Lincoln | Nebraska | 68522 | United States |
| Velocity Clinical Research, Norfolk | Recruiting | Norfolk | Nebraska | 68701 | United States |
| Cooper University Health Care | Not yet recruiting | Camden | New Jersey | 08103 | United States |
| Cooper University Health Care | Not yet recruiting | Cherry Hill | New Jersey | 08034 | United States |
| Family Health Center | Not yet recruiting | New Brunswick | New Jersey | 08901 | United States |
| Saint Peter's University Hospital | Not yet recruiting | New Brunswick | New Jersey | 08901 | United States |
| Cooper University Health Care | Not yet recruiting | Sewell | New Jersey | 08080 | United States |
| Stony Brook Medicine Clinical Research Center | Recruiting | East Setauket | New York | 11733 | United States |
| New York-Presbyterian Queens | Not yet recruiting | Flushing | New York | 11355 | United States |
| Obstetrical Center | Not yet recruiting | Fresh Meadows | New York | 11365 | United States |
| ACGC Research, NYU Ambulatory Care Garden City | Recruiting | Garden City | New York | 11530 | United States |
| NYU Langone Ambulatory Care Garden City | Recruiting | Garden City | New York | 11530 | United States |
| Jackson Heights Family Health Center | Not yet recruiting | Jackson Heights | New York | 11372 | United States |
| NYU Langone Long Island, Clinical Research Center 3-002 (Admin only) | Recruiting | Mineola | New York | 11501 | United States |
| Columbia University Irving Medical Center | Not yet recruiting | New York | New York | 10032 | United States |
| Weill Cornell Medicine - New York Presbyterian Hospital | Recruiting | New York | New York | 10065 | United States |
| Stony Brook University | Recruiting | Stony Brook | New York | 11794 | United States |
| Duke Vaccine and Trials Unit | Recruiting | Durham | North Carolina | 27703 | United States |
| Duke University - Main Hospital and Clinics | Recruiting | Durham | North Carolina | 27705 | United States |
| Duke University - Main Hospital and Clinics | Recruiting | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45206 | United States |
| University of Cincinnati Physicians Midtown | Recruiting | Cincinnati | Ohio | 45213 | United States |
| Hoxworth Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
| University of Cincinnati Medical Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
| University Hospitals | Recruiting | Cleveland | Ohio | 44106 | United States |
| Cincinnati Children's Hospital Medical Center Liberty | Recruiting | Liberty Township | Ohio | 45044 | United States |
| Cincinnati Children's Hospital Medical Center Mason | Recruiting | Mason | Ohio | 45040 | United States |
| Senders Pediatrics | Recruiting | South Euclid | Ohio | 44121 | United States |
| University of Cincinnati Medical Center West Chester | Recruiting | West Chester | Ohio | 45069 | United States |
| University of Cincinnati Physicians | Recruiting | West Chester | Ohio | 45069 | United States |
| UPMC Children's Hospital of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Magee Women's Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Tribe Clinical Research, LLC- Greer | Recruiting | Greer | South Carolina | 29650 | United States |
| Tribe Clinical Research at Parkside Pediatrics Five Forks | Recruiting | Simpsonville | South Carolina | 29681 | United States |
| Proactive Clinical Research LLC | Not yet recruiting | Edinburg | Texas | 78539 | United States |
| Memorial Hermann Memorial City Hospital | Recruiting | Houston | Texas | 77024 | United States |
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77024 | United States |
| Maximos Ob/Gyn | Recruiting | League City | Texas | 77573 | United States |
| Dr. Ruben Aleman and Associates | Not yet recruiting | McAllen | Texas | 78504 | United States |
| University of Utah Madsen Health Center - Women's Health | Recruiting | Salt Lake City | Utah | 84112 | United States |
| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
| University of Utah Clinical Neuroscience Center | Recruiting | Salt Lake City | Utah | 84132 | United States |
| University of Utah Hospital | Recruiting | Salt Lake City | Utah | 84132 | United States |
| Inova Fairfax Medical Campus | Recruiting | Falls Church | Virginia | 22042 | United States |
| Sentara Leigh Hospital | Recruiting | Norfolk | Virginia | 23502 | United States |
| The Group For Women - Kempsville Office | Recruiting | Norfolk | Virginia | 23502 | United States |
| Tidewater Physicians for Women | Recruiting | Norfolk | Virginia | 23502 | United States |
| Womens Care Center | Recruiting | Norfolk | Virginia | 23502 | United States |
| Virginia Physicians For Women (VPFW) | Recruiting | North Chesterfield | Virginia | 23235 | United States |
| Clinical Research Partners, LLC | Recruiting | Richmond | Virginia | 23226 | United States |
| Seattle Childrens Research Institute | Recruiting | Seattle | Washington | 98101 | United States |
| Seattle Childrens Hospital | Recruiting | Seattle | Washington | 98105 | United States |
| UW Medical Center Northwest | Recruiting | Seattle | Washington | 98133 | United States |
| UW Medical Center Montlake | Recruiting | Seattle | Washington | 98195 | United States |
| Marshfield Medical Center - Marshfield-(Hospital) | Not yet recruiting | Marshfield | Wisconsin | 54449 | United States |
| Marshfield Medical Center - Marshfield | Not yet recruiting | Marshfield | Wisconsin | 54449 | United States |
| Fundación Respirar | Recruiting | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1426ABP | Argentina |
| Clinica Del Niño Y La Madre | Recruiting | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Clinica Privada del Sol S.A | Recruiting | Córdoba | Córdoba Province | X5000IIH | Argentina |
| Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L | Recruiting | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Instituto de Maternidad y Ginecología Nuestra Señora de las Mercedes | Recruiting | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Centro de investigación Clínica OSECAC - Sede Jonas Salk | Recruiting | Buenos Aires | 1044 | Argentina |
| Equipo Ciencia | Recruiting | Buenos Aires | C1428BNF | Argentina |
| Hospital Público Materno Infantil | Recruiting | Salta | 4400 | Argentina |
| Centro de Pesquisa Clínica - Obras Sociais Irmã Dulce | Recruiting | Salvador | Estado de Bahia | 41680-430 | Brazil |
| Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN | Recruiting | Natal | Rio Grande do Norte | 59025050 | Brazil |
| Universidade Federal de Santa Maria. | Recruiting | Santa Maria | Rio Grande do Sul | 97105-900 | Brazil |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto | Recruiting | São José do Rio Preto | São Paulo | 15090000 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo | Not yet recruiting | São Paulo | São Paulo | Brazil |
| Canadian Center for Vaccinology | Recruiting | Halifax | Nova Scotia | B3K 6R8 | Canada |
| Kingston Health Sciences Centre - Kingston General Site | Recruiting | Kingston | Ontario | K7L 2V7 | Canada |
| CHU de Quebec-Universite Laval-Centre hospitalier de l'Universite Laval et Centre mere-enfant Soleil | Recruiting | Québec | Quebec | G1V 4G2 | Canada |
| FVR, Kokkolan rokotetutkimusklinikka | Recruiting | Kokkola | Keski-Pohjanmaa | 67100 | Finland |
| FVR, Oulun rokotetutkimusklinikka | Recruiting | Oulu | North Ostrobothnia | 90220 | Finland |
| FVR, Tampereen rokotetutkimusklinikka | Recruiting | Tampere | Pirkanmaa | 33100 | Finland |
| FVR, Seinäjoen rokotetutkimusklinikka | Recruiting | Seinäjoki | South Ostrobothnia | 60100 | Finland |
| FVR, Turun rokotetutkimusklinikka | Recruiting | Turku | Southwest Finland | 20520 | Finland |
| MeVac - Meilahti Vaccine Research Center | Recruiting | Helsinki | Uusimaa | 00290 | Finland |
| St.Mary's Hospital | Recruiting | Kurume | Fukuoka | 830-8543 | Japan |
| Sendai City Hospital | Recruiting | Sendai | Miyagi | 982-8502 | Japan |
| Beppu Medical Center | Recruiting | Beppu-shi | Oita Prefecture | 874-0011 | Japan |
| Osaka Habikino Medical Center | Recruiting | Habikino | Osaka | 583-8588 | Japan |
| Taniguchi Hospital | Recruiting | Izumisano | Osaka | 598-0043 | Japan |
| Yamanashi Prefectural Central Hospital | Recruiting | Kofu | Yamanashi | 400-8506 | Japan |
| Fukui Aiiku Hospital | Recruiting | Fukui | 910-0833 | Japan |
| Rakuwakai Otowa Hospital | Recruiting | Kyoto | 607-8062 | Japan |
| Shizuoka General Hospital | Recruiting | Shizuoka | 420-8527 | Japan |
| Panamerican Clinical Research Mexico S.A de C.V. Guadalajara. | Recruiting | Guadalajara | Jalisco | 44670 | Mexico |
| Arké SMO S.A. de C.V. | Recruiting | Mexico City | Mexico City | 06700 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Recruiting | Monterrey | Nuevo León | 64460 | Mexico |
| Unidad de Medicina Especializada SMA | Recruiting | San Juan del Río | Querétaro | 76800 | Mexico |
| Arké SMO S.A de C.V | Recruiting | Veracruz | 91900 | Mexico |
| Jeroen Bosch Hospital | Recruiting | 's-Hertogenbosch | North Brabant | 5223 GZ | Netherlands |
| Diakonessenhuis, locatie Utrecht | Recruiting | Utrecht | 3582 KE | Netherlands |
| UMC Utrecht - Wilhelmina Kinderziekenhuis | Recruiting | Utrecht | 3584 | Netherlands |
| Josha Research | Recruiting | Bloemfontein | Free State | 9301 | South Africa |
| REIMED Reiger Park | Recruiting | Boksburg | Gauteng | 1459 | South Africa |
| Wits RHI Shandukani Research Centre | Recruiting | Johannesburg | Gauteng | 2001 | South Africa |
| Setshaba Research Centre | Recruiting | Pretoria | Gauteng | 0152 | South Africa |
| Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit | Recruiting | Soweto | Gauteng | 1864 | South Africa |
| MRC Unit on Child And Adolescent Health | Recruiting | Cape Town | Western Cape | 7700 | South Africa |
| Gugulethu Green Clinic | Recruiting | Cape Town | Western Cape | 7750 | South Africa |
| Kangwon National University Hospital | Recruiting | Chuncheon | Gangwon-do | 24289 | South Korea |
| Chonnam National University Hospital | Recruiting | Gwangju | Kwangju-kwangyǒkshi | 61469 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 03080 | South Korea |
| Korea University Guro Hospital | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 08308 | South Korea |
| Keimyung University Dongsan Hospital | Recruiting | Daegu | Taegu-kwangyǒkshi | 42601 | South Korea |
| Kyung Hee University Hospital at Gangdong | Recruiting | Seoul | 05278 | South Korea |
| CHUS - Hospital Clinico Universitario | Recruiting | Santiago de Compostela | A Coruña [LA Coruña] | 15706 | Spain |
| Hospital Sant Joan de Déu | Recruiting | Esplugues de Llobregat | Barcelona [barcelona] | 08950 | Spain |
| Hospital Universitario Quironsalud Madrid | Recruiting | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Universitario de Torrejón | Recruiting | Torrejón de Ardoz | Madrid | 28850 | Spain |
| Hospital Universitario La Paz | Recruiting | Madrid | Madrid, Comunidad de | 28046 | Spain |
| Hospital Universitario HM Puerta del Sur | Recruiting | Madrid | Madrid, Comunidad de | 28938 | Spain |
| Hospital Antequera | Recruiting | Antequera | 29200 | Spain |
| Hospital Universitario La Zarzuela | Recruiting | Aravaca | 28023 | Spain |
| Hospital General Universitario Gregorio Marañon | Recruiting | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Quirónsalud Sagrado Corazón | Recruiting | Seville | 41013 | Spain |
| Instituto Hispalense de Pediatria- IHP1 | Recruiting | Seville | 41014 | Spain |
| Hsinchu Municipal Mackay Children's Hospital | Recruiting | Hsinchu | Hsinchu | 30046 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | 80756 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
| Mackay Memorial Hospital | Recruiting | Taipei | 10449 | Taiwan |
| Chang Gung Medical Foundation-Linkou Branch | Recruiting | Taoyuan | 333 | Taiwan |
| University Hospitals Bristol NHS Foundation Trust | Recruiting | Bristol | Bristol, CITY of | BS1 3NU | United Kingdom |
| St Michael's Hospital | Recruiting | Bristol | Bristol, CITY of | BS2 8EG | United Kingdom |
| Barnet Hospital | Recruiting | London | England | EN5 3DJ | United Kingdom |
| St. George's Hospital | Recruiting | London | England | SW17 0QT | United Kingdom |
| North Manchester General Hospital | Recruiting | Manchester | England | M8 5RB. | United Kingdom |
| The Royal Cornwall Hospital | Recruiting | Truro | England | TR1 3LJ | United Kingdom |
| Southampton General Hospital | Recruiting | Southampton | Hampshire | SO16 6YD | United Kingdom |
| St Mary's Hospital (Manchester University NHS Foundation Trust) | Recruiting | Manchester | Lancashire | M13 9WL | United Kingdom |
| Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital | Recruiting | London | London, CITY of | W2 1NY | United Kingdom |
| The John Radcliffe Hospital | Recruiting | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| The Princess Royal Hospital | Recruiting | Shropshire | Telford AND Wrekin | TF1 6TF | United Kingdom |
| Bristol Royal Hospital for Children | Recruiting | Bristol | BS2 8BJ | United Kingdom |
| Bristol Royal Infirmary | Recruiting | Bristol | BS2 8EX | United Kingdom |
| St James's University Hospital | Recruiting | Leeds | LS9 7TF | United Kingdom |
| Royal Free Hospital | Recruiting | London | NW32QG | United Kingdom |
| Wythenshawe Hospital | Recruiting | Manchester | M23 9LT | United Kingdom |
| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| C472675 | PEDIARIX |
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
Not provided
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