Active Comparator Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
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Participants will receive a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
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Biological: Prevnar 13™
Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
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Biological: RotaTeq™
RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
Other names:
- V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: Pentacel™
Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: RECOMBIVAX HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: HIBERIX™
HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: M-M-R™ II
M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: VARIVAX™
VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Experimental Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
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Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
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Biological: Prevnar 13™
Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
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Biological: V114
V114 contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose given via IM injection.
Other names:
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Biological: RotaTeq™
RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
Other names:
- V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
-
Biological: Pentacel™
Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: RECOMBIVAX HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: HIBERIX™
HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: M-M-R™ II
M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: VARIVAX™
VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Experimental Group 3: Prevnar 13™-Prevnar 13™-V114-V114
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Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
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Biological: Prevnar 13™
Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
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Biological: V114
V114 contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose given via IM injection.
Other names:
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Biological: RotaTeq™
RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
Other names:
- V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
-
Biological: Pentacel™
Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: RECOMBIVAX HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: HIBERIX™
HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: M-M-R™ II
M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: VARIVAX™
VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Experimental Group 4: Prevnar 13™-V114-V114-V114
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Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
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Biological: Prevnar 13™
Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
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Biological: V114
V114 contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose given via IM injection.
Other names:
-
Biological: RotaTeq™
RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
Other names:
- V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
-
Biological: Pentacel™
Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
-
Biological: RECOMBIVAX HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
-
Biological: HIBERIX™
HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Biological: M-M-R™ II
M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
-
Biological: VARIVAX™
VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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Experimental Group 5: V114-V114-V114-V114
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Participants will receive a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
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Biological: V114
V114 contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose given via IM injection.
Other names:
-
Biological: RotaTeq™
RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
Other names:
- V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
-
Biological: Pentacel™
Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
-
Biological: RECOMBIVAX HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
-
Biological: HIBERIX™
HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
-
Biological: M-M-R™ II
M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
-
Biological: VARIVAX™
VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Other names:
- V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
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