Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133445
Status:
COMPLETED
Last Update Posted:
2011-11-06
First Post:
2005-08-19
Brief Title:
Pentavalent DTaP-Hep B-IPV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Randomized Single Blinded Study of the Safety and Immunogenicity of Pentavalent DTaP-Hep B-IPV Combination Vaccine Pediarix GlaxoSmithKline GSK Biologicals Administered to Healthy Neonates and Infants at Birth 2 and 6 Months of Age Compared to a Routine Infant Schedule at 2 4 and 6 Months of Age
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety of administering a combination vaccine DTaP-HepB-IPV Pediarix to infants at birth 2 and 6 months compared to the administration of a HepB vaccine at birth and the same combination vaccine at 2 4 and 6 months of age Additionally researchers will assess the bodys antibody response proteins produced by the bodys immune system that help fight infections following each vaccine dose The study will enroll 5 healthy newborns ages 0-5 days Participants will be involved in study related procedures for up to 288 days including blood sample collection and 5 study visits
Detailed Description:
Routine immunization at birth is standard for hepatitis B in the United States US and for hepatitis B polio and tuberculosis BCG in many countries Other vaccines have not been routinely administered at birth largely due to concerns relating to immaturity of the neonatal immune system and the possibility of reduced immune response to vaccine antigens With the recent licensure in the US of a pentavalent combination vaccine DTaP-Hep B-IPV Pediarix researchers propose to evaluate a new immunization schedule that includes a birth dose of this vaccine in an effort to determine adequacy of neonatal immune response to the study vaccine antigens The primary objectives of this study are to evaluate the safety of administering the pentavalent combination vaccine DTaP-HepB-IPV Pediarix to infants at birth two and six months of age compared to the administration of a hepatitis B vaccine Engerix-B at birth and the same pentavalent combination vaccine at two four and six months of age and to assess age specific antibody response following each vaccine dose Five healthy newborns 0 to 5 days of age greater than or equal to 37 weeks gestation and greater than 2500 gm birth weight were recruited from two Southern California Kaiser Permanente medical centers Infants were randomized to one of 2 study groups Group A received DTaP-HepB-IPV Pediarix vaccine along with other required vaccines at birth two six months of age Group B received the monovalent hepatitis B vaccine Engerix-B at birth the DTaP-HepB-IPV Pediarix vaccine with other vaccines at two four and six months Children will be evaluated for post-vaccination adverse events Blood will be collected and immunogenicity evaluated by standardized humoral immunologic assays The main outcome measures are to assess immune responses to each vaccine antigen over time antibodies to pertussis PT FHA PRN diphtheria tetanus haemophilus influenzae type b Hib polio Types 1 2 3 and hepatitis B HbsAg The secondary outcome measures are to assess vaccine safety systemic and local immediate reactions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None