Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
OTHER · MCMVaccBV Protocol ID
OTHER · Merck Protocol Number
interventional
385
0 countries
N/A
Study Start
May 1, 2013
Actual (reported)Primary Completion
March 19, 2014
Actual (reported)Study Completion
March 19, 2014
Actual (reported)To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age Primary objectives
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 19, 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 19, 2013
Actual (reported)April 24, 2013
Actual (reported)May 1, 2013
Actual (reported)March 19, 2014
Actual (reported)March 19, 2014
Actual (reported)February 25, 2019
Actual (reported)Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL
The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg.
Month 5 (one month after receiving Vaccination 3)
Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL
The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide.
Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg)
Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen
Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentration of Antibodies to Diphtheria Toxin
Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentration of Antibodies to Tetanus Toxin
Month 5 (one month after receiving Vaccination 3)
Geometric Mean Concentrations of Antibodies to Pertussis Antigens
Month 5 (one month after receiving Vaccination 3)
\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.
Hexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed \[DTaP\], Hepatitis B \[HB; Recombinant DNA\], Inactivated Poliovirus \[IPV\], and Haemophilus influenzae type b \[Hib\] conjugate vaccine \[adsorbed\]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age.
Martinon-Torres F, Boisnard F, Thomas S, Sadorge C, Borrow R; PRI02C study group. Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib). Vaccine. 2017 Jun 27;35(30):3764-3772. doi: 10.1016/j.vaccine.2017.05.043. Epub 2017 Jun 2.
Medical Director
Merck Sharp & Dohme LLC
385 participants (actual enrollment reported by the registry).
First Submitted
April 19, 2013
First Posted
April 24, 2013
Study Start
May 1, 2013
Actual (reported)Primary Completion
Pentavalent Pediacel® vaccine (DTaP-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed \[DTaP\], Inactivated Poliovirus \[IPV\], and Haemophilus influenzae type b \[Hib\] conjugate vaccine \[adsorbed\]) at 0.5 mL for IM injection (left upper thigh) at 4 months of age.
Meningococcal group C (MCC) polysaccharide conjugate vaccine (adsorbed) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.
Human-bovine rotavirus reassortants (live) vaccine 2 mL oral administration at 2, 4 and 6 months of age. RotaTeq® administered prior to any other vaccine administration to avoid having the infant participants spit up the RotaTeq® when crying.
Pneumococcal polysaccharide conjugate vaccine \[PCV; 13-valent, adsorbed\]) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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March 19, 2014
Actual (reported)Study Completion
March 19, 2014
Actual (reported)Last Updated
February 25, 2019
Results First Posted
February 25, 2019
Record last verified: 2019-02
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Source: ClinicalTrials.gov.
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