This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine

Rotavirus Infection Clinical Trial

Official title:
Immunogenicity, Reactogenicity and Safety Study of Pediarix®, Hiberix® and Prevenar 13® Co-administered With Two Different Formulations of GSK Biologicals' HRV Vaccine (444563) in Healthy Infants 6-12 Weeks of Age

Status Completed

Clinical Trial Summary

The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03207750
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 3
Start date	September 14, 2017
Completion date	March 1, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02914184` - Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks	Phase 3
Completed	`NCT00241644` - Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants	Phase 3
Completed	`NCT01733862` - Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis
Completed	`NCT00353366` - To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
Unknown status	`NCT00669929` - Cost-Effectiveness Analysis of Rotavirus Vaccination for Children in Korea	N/A
Completed	`NCT00432380` - A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.	Phase 2
Completed	`NCT05037435` - Safety and Immunological Efficacy of the Pentavalent Rotavirus Vaccine - Rota-V-Aid™ (Live Attenuated Oral, Freeze-dried) at Healthy Adults Aged 18 to 45 Years.	Phase 3
Completed	`NCT00480324` - Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants	Phase 3
Not yet recruiting	`NCT03804489` - Using "Decision Aids" to Help the Infant Family to Decide the Use of Oral Rotavirus Vaccine	N/A
Completed	`NCT00595205` - Intussusception Surveillance After Rotarix Introduction in Mexico	N/A
Completed	`NCT01177826` - Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children
Completed	`NCT00995813` - Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure	Phase 4
Completed	`NCT00969228` - Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants	Phase 4