Clinical trials: Healthy Infants
Hypertension
A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults
The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults.
- Trial name
- NCT01078376
- Testing
- Azilsartan medoxomil (TAK-491)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Takeda
Pneumococcal Infections, Pneumococcal Vaccines
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114…
- Trial name
- PNEU-PED (NCT03893448)
- Testing
- V114, Prevnar 13™, RotaTeq™
- Where
- 81 sites in United States, Puerto Rico and 2 more
- Volunteers
- 1,720 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Poliomyelitis
Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants
The study will evaluate the safety and reactogenicity of Poliorix given as primary vaccination course to Chinese children at 2, 3 and 4 months of age.
- Trial name
- NCT00937404
- Testing
- Poliorix
- Where
- China
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Infection
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.
- Trial name
- NCT01340898
- Testing
- Meningococcal vaccine GSK 134612, SynflorixTM, Infanrix-IPV/HiberixTM
- Where
- 2 sites in Lebanon, Mexico
- Volunteers
- 753 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Vaccines, Combined, Hexavalent Vaccine
Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)
The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of a booster dose of Vaxelis™ (V419) given at ~11 to 13 months of age in healthy participants who were previously vaccinated with a…
- Trial name
- NCT05289271
- Testing
- Vaxelis™
- Where
- 13 sites in Germany, Italy and 1 more
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Meningitis, Meningococcal, Rotavirus Infections
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine.
- Trial name
- NCT00443846
- Testing
- RotaTeq®, NeisVac-C®
- Volunteers
- 247 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam
The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in…
- Trial name
- NCT01153841
- Testing
- Synflorix™( GSK1024850A), Infanrix hexa™
- Where
- Vietnam
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus, Gastroenteritis
Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)
The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.
- Trial name
- NCT00718237
- Testing
- Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
- Volunteers
- 762 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis
A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects.
- Trial name
- NCT03227471
- Testing
- IVA, TEZ/IVA, VX-445
- Where
- 38 sites in United States, Australia and 2 more
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Infections, Meningococcal, Meningococcal Vaccines
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines
The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age.
- Trial name
- NCT01144663
- Testing
- Nimenrix™, Menjugate®, NeisVac-CTM
- Where
- 44 sites in Estonia, Germany and 1 more
- Volunteers
- 2,095 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing
Primary: The rating by the primary caregivers on the use and relevance of data provided by the Language ENvironment Analysis (LENA) recorder and their level of engagement due to the content on the Cool mobile app.
- Trial name
- COOL (NCT03729960)
- Testing
- LENA recorder
- Where
- Singapore
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Healthy
MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the…
- Trial name
- NCT00121108
- Testing
- Motavizumab
- Where
- 12 sites in United States
- Volunteers
- 2,127 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Pneumococcal Infections
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations…
- Trial name
- NCT00452790
- Testing
- 13-valent Pneumococcal Conjugate Vaccine, 7 valent pneumococcal conjugate vaccine
- Where
- 12 sites in India
- Volunteers
- 708 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine.
- Trial name
- NCT01480258
- Testing
- PR5I, Rotavirus vaccine, Prevenar 13™
- Volunteers
- 1,315 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Infections, Streptococcal
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants
This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by…
- Trial name
- NCT01204658
- Testing
- Pneumococcal vaccine GSK 2189242A (LD formulation 1), Pneumococcal vaccine GSK 2189242A (HD formulation 2), Synflorix
- Where
- 24 sites in Czechia, Germany and 2 more
- Volunteers
- 576 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
RSV Immunization, Healthy Volunteer
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection…
- Trial name
- NCT05437510
- Testing
- Nirsevimab
- Where
- 240 sites in France, Germany and 1 more
- Volunteers
- 8,057 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Vaccines, Pneumococcal Conjugate Vaccine
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly…
- Trial name
- NCT00688870
- Testing
- 13-valent pneumococcal conjugate vaccine (13vPnC), 7-valent pneumococcal conjugate vaccine (7vPnC)
- Where
- 2 sites in Taiwan
- Volunteers
- 168 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Pneumococcal Disease
A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers
In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccine (Group 2) or DTaP alone…
- Trial name
- NCT01298544
- Testing
- Blood draw
- Where
- 10 sites in China
- Volunteers
- 335 people, healthy volunteers welcome
- Sponsor
- Pfizer
Cystic Fibrosis
To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration
This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects
- Trial name
- NCT02679729
- Testing
- AZD5634 for inhalation, AZD5634 for infusion
- Where
- 2 sites in United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Infections, Rotavirus
Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)
This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with human…
- Trial name
- NCT00329745
- Testing
- Rotarix™
- Where
- 4 sites in Singapore
- Volunteers
- 8,687 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline