Trial Outcomes & Findings for Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children (NCT NCT01545375)

Last Updated: 2019-12-27

Results Overview

Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T\[year)\]). Definition of clinical AOM diagnosed and verified against AAP criteria required meeting three criteria based on the guidelines from the AAP \[AAP, 2004\], as per the judgment of a treating physician or equivalent licensed medical professional: A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND The presence of MEE indicated by any of the following: a) Bulging of tympanic membrane; b) Limited or absent mobility of tympanic membrane; c) Air-fluid level behind tympanic membrane; d) Otorrhea AND Signs or symptoms of middle-ear inflammation as indicated by either: a) Distinct erythema of tympanic membrane or b) Distinct otalgia (discomfort clearly referable to the ear\[s\] that resulted in interference with or precluded normal activity or sleep).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1806 participants

Primary outcome timeframe

Any time from 2 weeks after the administration of dose 3 up to Month 22

Results posted on

2019-12-27

Participant Flow

1806 subjects were enrolled in this study, Three sub-cohorts of subjects were foreseen: Immuno/reacto sub-cohort for assessment of immunogenicity, Carriage sub-cohort for assessment of impact on carriage of S. pneumoniae and "No additional procedures" sub-cohort comprising subjects not included in any of the above sub-cohorts.

Out of the 1806 subjects enrolled in this study, 1803 were vaccinated and therefore included in the Total Vaccinated Cohort. 3 subjects were excluded for the following reasons: one subject had an invalid Inform Consent form and 2 subjects received subject number but did not receive any vaccine dose.

Participant milestones

Participant milestones
Measure	dPly-PhtD Group Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Overall Study STARTED	900	903
Overall Study COMPLETED	803	813
Overall Study NOT COMPLETED	97	90

Reasons for withdrawal

Reasons for withdrawal
Measure	dPly-PhtD Group Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Overall Study Adverse Event	2	1
Overall Study Lost to Follow-up	34	31
Overall Study Protocol Violation	3	3
Overall Study Withdrawal by Subject	58	55

Baseline Characteristics

Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	dPly-PhtD Group n=900 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=903 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Total n=1803 Participants Total of all reporting groups
Age, Continuous	7.7 Weeks STANDARD_DEVIATION 1.69 • n=5 Participants	7.6 Weeks STANDARD_DEVIATION 1.65 • n=7 Participants	7.6 Weeks STANDARD_DEVIATION 1.67 • n=5 Participants
Sex: Female, Male Female	459 Participants n=5 Participants	441 Participants n=7 Participants	900 Participants n=5 Participants
Sex: Female, Male Male	441 Participants n=5 Participants	462 Participants n=7 Participants	903 Participants n=5 Participants
Race/Ethnicity, Customized American indian or Alaskan native · American Indian or Alaskan Native	900 Participants n=5 Participants	903 Participants n=7 Participants	1803 Participants n=5 Participants

PRIMARY outcome

Timeframe: Any time from 2 weeks after the administration of dose 3 up to Month 22

Population: Analysis was performed on the modified according to protocol cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=808 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=831 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria	0.425 Episodes per person-year	0.442 Episodes per person-year

SECONDARY outcome

Timeframe: Any time from 2 weeks after the administration of dose 3 up to Month 22

Population: Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.

Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T\[year)\]). A healthcare-provider-diagnosed clinical AOM case was defined as an AOM event diagnosed by a treating physician or equivalent licensed medical professional with or without clinical symptoms documented in the routine medical record.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=808 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=831 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider	0.678 Episodes per person-year	0.699 Episodes per person-year

SECONDARY outcome

Timeframe: Any time from 2 weeks after the administration of dose 3 up to Month 22

Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T\[year)\]). Definition of clinical AOM diagnosed and verified against modified AAP criteria required a history of acute disease (i.e. AAP criterion 1) together with abnormal tympanic membrane (i.e. one of the AAP criteria 2 or 3a), as per the judgment of a treating physician or equivalent licensed medical professional: 1. A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND 2. The presence of MEE that is indicated by any of the following: a) Bulging of tympanic membrane, b) Limited or absent mobility of tympanic membrane, c) Air-fluid level behind tympanic membrane, d) Otorrhea OR 3. Signs or symptoms of middle-ear inflammation as indicated by: a) Distinct erythema of tympanic membrane.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=808 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=831 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria	0.567 Episodes per person-year	0.599 Episodes per person-year

SECONDARY outcome

Timeframe: From the administration of dose 1 up to Month 22

Population: Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.

Recurrent AOM was defined as at least 3 AOM episodes diagnosed by a physician or equivalent licensed medical professional and occurring within 6 months or at least 4 episodes within one year, regardless of the etiology.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=900 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=903 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM)	30 Participants	32 Participants

SECONDARY outcome

Timeframe: Any time from 2 weeks after the administration of dose 3 up to Month 22

Population: Analysis was performed on the modified ATP for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.

Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T\[year)\]). Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=808 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=831 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Time to Occurrence of Any Draining Acute Otitis Media (AOM)	0.055 Episodes per person-year	0.060 Episodes per person-year

SECONDARY outcome

Timeframe: Any time from 2 weeks after the administration of dose 3 up to Month 22

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=808 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=831 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Time to Occurrence of Any Draining Pneumococcal Acute Otitis Media (AOM)	0.008 Episodes per person-year	0.006 Episodes per person-year

SECONDARY outcome

Timeframe: From the administration of dose 1 up to Month 22

Population: Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.

AOM with temporally related carriage was defined as AOM with nasopharyngeal swab taken within 3 days before or after an AOM episode.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=900 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=903 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Number of Subjects With Any Acute Otitis Media (AOM) With Temporally Related Carriage	338 Participants	368 Participants

SECONDARY outcome

Timeframe: Any time from 2 weeks after the administration of dose 3 up to Month 22

Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T\[year)\]). ALRI was defined by the presence of tachypnea (respiratory rate \>50 amongst children 2 to 12 months of age, and respiratory rate \>40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever was defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=808 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=831 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Time to Occurrence of Medically Attended Acute Lower Respiratory Tract Infection (ALRI)	0.143 Episodes per person-year	0.141 Episodes per person-year

SECONDARY outcome

Timeframe: Any time from 2 weeks after the administration of dose 3 up to Month 22

Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T\[year)\]). ALRI was defined by the presence of tachypnea (respiratory rate \>50 amongst children 2 to 12 months of age, and respiratory rate \>40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever is defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=808 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=831 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Time to Occurrence of Medically Attended ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode	0.109 Episodes per person-year	0.105 Episodes per person-year

SECONDARY outcome

Timeframe: Any time from 2 weeks after the administration of dose 3 up to Month 22

Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T\[year)\]). A healthcare-provider-diagnosed ALRI with fever case was defined as, but not limited to, chest infection, bronchiolitis, pneumonia, bronchopneumonia, pleural effusion or empyema diagnosed by a treating physician or equivalent licensed medical professional with fever documented at the time of visit or history of fever within 3 days preceding a given episode and with or without other clinical symptoms documented in the routine medical record.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=808 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=831 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Time to Occurrence of Any Medically Attended Healthcare-provider-diagnosed ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode.	0.253 Episodes per person-year	0.259 Episodes per person-year

SECONDARY outcome

Timeframe: At 7 months of age (Month 5), 12-15 months of age (Month 10),18-22 months of age (Month 16) and 24-27 months of age (Month 22)

Population: Analysis was performed on the Total vaccinated cohort for carriage which included around 400 subjects not included in the immuno/reacto sub-cohort, who had received at least one vaccination dose and for whom data concerning carriage outcome measures were available.

Positive cultures of S. pneumoniae (any and serotype specific) identified in the nasopharynx were analyzed.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=355 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=359 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Number of Subjects With S. Pneumoniae (Any and Serotype Specific) in the Nasopharynx - Carriage Sub-cohort Month 5	202 Participants	224 Participants
Number of Subjects With S. Pneumoniae (Any and Serotype Specific) in the Nasopharynx - Carriage Sub-cohort Month 10	201 Participants	213 Participants
Number of Subjects With S. Pneumoniae (Any and Serotype Specific) in the Nasopharynx - Carriage Sub-cohort Month 16	192 Participants	213 Participants
Number of Subjects With S. Pneumoniae (Any and Serotype Specific) in the Nasopharynx - Carriage Sub-cohort Month 22	204 Participants	223 Participants

SECONDARY outcome

Timeframe: One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively

Population: Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available.

Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations equal to (=) 12 EL.U/mL for anti-Ply antibodies and = 17 EL.U/mL for anti-PhtD antibodies.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=116 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=120 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort Anti-Ply-PIII (Month 5)	24206.23 EL.U/mL Interval 21618.31 to 27103.95	1063.15 EL.U/mL Interval 853.29 to 1324.63
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort Anti-Ply-Pre-booster (Month 10)	13108.68 EL.U/mL Interval 10959.48 to 15679.36	2245.92 EL.U/mL Interval 1845.51 to 2733.21
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort Anti-Ply-Post-booster (Month 11)	36234.97 EL.U/mL Interval 33306.01 to 39421.51	2658.05 EL.U/mL Interval 2191.75 to 3223.55
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort Anti-Ply-Post-booster (Month 22)	19390.01 EL.U/mL Interval 17011.67 to 22100.85	4639.15 EL.U/mL Interval 3954.54 to 5442.29
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort Anti-PhtD-PIII (Month 5)	4144.62 EL.U/mL Interval 3469.43 to 4951.2	989.65 EL.U/mL Interval 778.36 to 1258.29
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort Anti-PhtD-Pre-booster (Month 10)	2625.77 EL.U/mL Interval 2189.2 to 3149.41	2271.53 EL.U/mL Interval 1730.59 to 2981.55
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort Anti-PhtD-Post-booster (Month 11)	8680.76 EL.U/mL Interval 7489.85 to 10061.04	2324.28 EL.U/mL Interval 1768.42 to 3054.87
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort Anti-PhtD-Post-booster (Month 22)	5248.38 EL.U/mL Interval 4650.71 to 5922.86	5535.93 EL.U/mL Interval 4776.89 to 6415.59

SECONDARY outcome

Timeframe: One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively

Population: The analysis was to be performed on the according to protocol cohort for immunogenicity. But inhibition of Ply hemolysis activity was not evaluated due to assay stability issues.

Inhibition of Ply hemolysis activity was not evaluated due to assay stability issues.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)], 1 month post-booster dose [Post-booster(Month 11)], 12 months post-booster dose [Post-booster(Month 22)]

Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=115 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=119 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Immuno/Reacto Sub-cohort Anti-PRP PIII (Month 5)	4.65 µg/mL Interval 3.4 to 6.34	6.66 µg/mL Interval 5.02 to 8.85
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Immuno/Reacto Sub-cohort Anti-PRP Pre-booster (Month 10)	0.90 µg/mL Interval 0.69 to 1.19	1.12 µg/mL Interval 0.85 to 1.46
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Immuno/Reacto Sub-cohort Anti-PRP Post-booster (Month 11)	12.32 µg/mL Interval 9.02 to 16.82	17.28 µg/mL Interval 13.15 to 22.69
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Immuno/Reacto Sub-cohort Anti-PRP Post-booster (Month 22)	1.51 µg/mL Interval 1.16 to 1.95	1.84 µg/mL Interval 1.48 to 2.29

SECONDARY outcome

Timeframe: One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)]

Antibody concentrations were measured by Electro-chemiluminescence assay (ECL), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was a serotype-specific antibody concentration higher than or equal to (≥) LLOQ (Lower Limit of Quantification) expressed in µg/mL: 0.08 for Anti-1; 0.075 for anti-3; 0.061 for Anti-4; 0.198 for Anti-5; 0.111 for Anti-6A and Anti-18C; 0.102 for Anti-6B; 0.063 for Anti-7F; 0.066 for Anti-9V; 0.160 for Anti-14; 0.199 for Anti-19A; 0.163 for Anti-19F; 0.073 for Anti-23F.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=112 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=118 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-1 PIII(Month 5)	3.35 µg/mL Interval 2.91 to 3.86	3.18 µg/mL Interval 2.8 to 3.62
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-1 Pre-Booster (Month 10)	0.57 µg/mL Interval 0.5 to 0.65	0.55 µg/mL Interval 0.49 to 0.62
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-1 Post-Booster (Month 11)	4.45 µg/mL Interval 3.83 to 5.17	4.83 µg/mL Interval 4.16 to 5.59
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-3 PIII(Month 5)	0.59 µg/mL Interval 0.52 to 0.67	0.52 µg/mL Interval 0.47 to 0.58
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-3 Pre-Booster (Month 10)	0.16 µg/mL Interval 0.14 to 0.2	0.13 µg/mL Interval 0.11 to 0.15
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-3 Post-Booster (Month 11)	0.66 µg/mL Interval 0.59 to 0.75	0.57 µg/mL Interval 0.51 to 0.64
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-4 PIII(Month 5)	2.05 µg/mL Interval 1.79 to 2.35	1.98 µg/mL Interval 1.75 to 2.24
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-4 Pre-Booster (Month 10)	0.34 µg/mL Interval 0.3 to 0.38	0.31 µg/mL Interval 0.27 to 0.35
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-4 Post-Booster (Month 11)	3.98 µg/mL Interval 3.35 to 4.73	3.85 µg/mL Interval 3.23 to 4.59
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-5 PIII(Month 5)	2.4 µg/mL Interval 2.09 to 2.77	2.41 µg/mL Interval 2.12 to 2.73
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-5 Pre-Booster (Month 10)	0.66 µg/mL Interval 0.58 to 0.76	0.61 µg/mL Interval 0.53 to 0.69
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-5 Post-Booster (Month 11)	4.24 µg/mL Interval 3.68 to 4.89	3.98 µg/mL Interval 3.48 to 4.56
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6A PIII(Month 5)	5.27 µg/mL Interval 4.55 to 6.11	4.74 µg/mL Interval 4.13 to 5.43
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6A Pre-Booster (Month 10)	0.97 µg/mL Interval 0.85 to 1.11	0.9 µg/mL Interval 0.78 to 1.03
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6A Post-Booster (Month 11)	10.31 µg/mL Interval 9.0 to 11.82	10.28 µg/mL Interval 8.89 to 11.89
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6B PIII(Month 5)	3.5 µg/mL Interval 2.9 to 4.23	3.31 µg/mL Interval 2.74 to 4.0
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6B Pre-Booster (Month 10)	0.66 µg/mL Interval 0.56 to 0.79	0.64 µg/mL Interval 0.54 to 0.76
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6B Post-Booster (Month 11)	10.03 µg/mL Interval 8.68 to 11.6	9.62 µg/mL Interval 8.24 to 11.25
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-7F PIII(Month 5)	4.47 µg/mL Interval 3.99 to 5.0	4.35 µg/mL Interval 3.87 to 4.89
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-7F Pre-Booster (Month 10)	0.89 µg/mL Interval 0.79 to 1.01	0.87 µg/mL Interval 0.78 to 0.97
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-7F Post-Booster (Month 11)	6.61 µg/mL Interval 5.81 to 7.53	6.65 µg/mL Interval 5.82 to 7.59
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-9V PIII(Month 5)	2.22 µg/mL Interval 1.89 to 2.62	2.24 µg/mL Interval 1.97 to 2.53
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-9V Pre-Booster (Month 10)	0.43 µg/mL Interval 0.37 to 0.5	0.45 µg/mL Interval 0.39 to 0.52
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-9V Post-Booster (Month 11)	4.14 µg/mL Interval 3.52 to 4.88	4.38 µg/mL Interval 3.78 to 5.08
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-14 PIII(Month 5)	8.46 µg/mL Interval 7.04 to 10.16	8.78 µg/mL Interval 7.67 to 10.04
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-14 Pre-Booster (Month 10)	1.79 µg/mL Interval 1.51 to 2.11	1.83 µg/mL Interval 1.6 to 2.1
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-14 Post-Booster (Month 11)	13.22 µg/mL Interval 11.35 to 15.4	13.14 µg/mL Interval 11.22 to 15.39
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-18C PIII(Month 5)	2.51 µg/mL Interval 2.2 to 2.87	2.33 µg/mL Interval 2.05 to 2.64
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-18C Pre-Booster (Month 10)	0.38 µg/mL Interval 0.33 to 0.44	0.34 µg/mL Interval 0.29 to 0.39
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-18C Post-Booster (Month 11)	5.41 µg/mL Interval 4.63 to 6.32	5.28 µg/mL Interval 4.46 to 6.25
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19A PIII(Month 5)	2.65 µg/mL Interval 2.29 to 3.06	2.86 µg/mL Interval 2.46 to 3.33
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19A Pre-Booster (Month 10)	0.57 µg/mL Interval 0.47 to 0.68	0.61 µg/mL Interval 0.5 to 0.74
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19A Post-Booster (Month 11)	7.64 µg/mL Interval 6.58 to 8.87	8.07 µg/mL Interval 6.92 to 9.42
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19F PIII(Month 5)	3.61 µg/mL Interval 3.18 to 4.09	3.60 µg/mL Interval 3.17 to 4.09
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19F Pre-Booster (Month 10)	0.78 µg/mL Interval 0.67 to 0.92	0.84 µg/mL Interval 0.72 to 0.98
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19F Post-Booster (Month 11)	7.96 µg/mL Interval 6.92 to 9.17	8.23 µg/mL Interval 7.13 to 9.49
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-23F PIII(Month 5)	1.97 µg/mL Interval 1.64 to 2.36	2.04 µg/mL Interval 1.72 to 2.43
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-23F Pre-Booster (Month 10)	0.36 µg/mL Interval 0.3 to 0.43	0.39 µg/mL Interval 0.32 to 0.47
Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-23F Post-Booster (Month 11)	3.71 µg/mL Interval 3.16 to 4.36	3.97 µg/mL Interval 3.27 to 4.83

SECONDARY outcome

Timeframe: One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)]

Population: The analysis was to be performed on the ATP cohort for immunogenicity. But no analysis was performed for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.

No analysis was performed on antibody concentrations against vaccine-related serotype 6C as no specific qualified/validated assay was available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)]

Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) LLOQ: 8 for OPA-1, OPA-3 and OPA-6B; 33 for OPA-4, and OPA-14; 50 for OPA-5; 151 for OPA-6A; 330 for OPA-7F; 275 for OPA-9V; 11 for OPA-18C; 143 for OPA-19A; 36 for OPA-19F; 101 for OPA-23F.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=57 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=59 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-1 PIII(Month 5)	76.0 Titers Interval 43.0 to 134.4	32.9 Titers Interval 20.2 to 53.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-1 Post-Booster (Month 11)	191.0 Titers Interval 114.9 to 317.7	219.7 Titers Interval 134.7 to 358.5
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-3 PIII(Month 5)	319.9 Titers Interval 233.3 to 438.8	190.1 Titers Interval 140.9 to 256.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-3 Post-Booster (Month 11)	452.4 Titers Interval 342.1 to 598.3	399.5 Titers Interval 294.1 to 542.5
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-4 PIII(Month 5)	1450.4 Titers Interval 1159.2 to 1814.7	1397.8 Titers Interval 1136.3 to 1719.3
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-4 Post-Booster (Month 11)	2657.2 Titers Interval 2254.7 to 3131.6	2592.5 Titers Interval 2167.7 to 3100.5
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-5 PIII(Month 5)	792.7 Titers Interval 610.0 to 1030.0	464.7 Titers Interval 337.7 to 639.4
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-5 Post-Booster (Month 11)	1541.5 Titers Interval 1254.2 to 1894.8	1192.6 Titers Interval 857.8 to 1658.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-6A PIII(Month 5)	4945.3 Titers Interval 3877.7 to 6306.7	5231.7 Titers Interval 4349.7 to 6292.6
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-6A Post-Booster (Month 11)	9149.5 Titers Interval 7640.0 to 10957.2	10266.5 Titers Interval 8902.8 to 11839.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-6B PIII(Month 5)	2754.9 Titers Interval 2168.1 to 3500.4	2140.1 Titers Interval 1443.9 to 3172.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-6B Post-Booster (Month 11)	5909.9 Titers Interval 4895.5 to 7134.4	5663.3 Titers Interval 4502.2 to 7123.9
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-7F PIII(Month 5)	8429.3 Titers Interval 6931.1 to 10251.3	7539.0 Titers Interval 6295.3 to 9028.4
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-7F Post-Booster (Month 11)	10746.6 Titers Interval 9081.4 to 12717.2	9504.8 Titers Interval 7707.8 to 11720.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-9V PIII(Month 5)	2391.3 Titers Interval 1699.5 to 3364.6	2728.4 Titers Interval 2002.2 to 3718.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-9V Post-Booster (Month 11)	6001.1 Titers Interval 4904.8 to 7342.4	6206.9 Titers Interval 4806.4 to 8015.5
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-14 PIII(Month 5)	2236.4 Titers Interval 1722.1 to 2904.2	1988.5 Titers Interval 1437.7 to 2750.3
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-14 Post-Booster (Month 11)	3981.9 Titers Interval 3233.2 to 4904.0	3856.0 Titers Interval 3011.3 to 4937.7
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-18C PIII(Month 5)	1927.9 Titers Interval 1532.7 to 2425.1	1736.2 Titers Interval 1346.8 to 2238.1
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-18C Post-Booster (Month 11)	4240.3 Titers Interval 3345.8 to 5374.0	4349.6 Titers Interval 3437.7 to 5503.4
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-19A PIII(Month 5)	2204.4 Titers Interval 1626.0 to 2988.4	2060.2 Titers Interval 1590.9 to 2668.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-19A Post-Booster (Month 11)	5630.3 Titers Interval 4474.1 to 7085.2	6447.5 Titers Interval 5235.0 to 7941.0
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-19F PIII(Month 5)	1355.0 Titers Interval 1018.9 to 1802.1	1112.4 Titers Interval 785.0 to 1576.2
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-19F Post-Booster (Month 11)	3222.8 Titers Interval 2513.5 to 4132.2	2574.0 Titers Interval 1838.8 to 3603.2
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-23F PIII(Month 5)	3072.8 Titers Interval 2473.1 to 3817.9	2634.9 Titers Interval 1991.9 to 3485.5
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes OPA-23F Post-Booster (Month 11)	6240.2 Titers Interval 5555.3 to 7009.4	5958.6 Titers Interval 5117.3 to 6938.2

SECONDARY outcome

Timeframe: One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)]

Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine-related pneumococcal serotypes 6C (OPA-6C). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 145.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=45 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=54 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C OPA-6C PIII(Month 5)	3161.8 Titers Interval 2369.0 to 4219.8	2616.6 Titers Interval 1924.2 to 3558.2
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C OPA-6C Post-Booster (Month 11)	5151.0 Titers Interval 4003.5 to 6627.3	5637.2 Titers Interval 4436.4 to 7163.1

SECONDARY outcome

Timeframe: Within the 4-day (Days 0-3) post-primary vaccination period following each dose

Population: Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented.

Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=198 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=197 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Pain, post Dose 1	149 Participants	131 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Pain, post Dose 1	38 Participants	36 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Redness, post Dose 1	59 Participants	58 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Redness, post Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Swelling, post Dose 1	35 Participants	28 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Pain, post Dose 3	96 Participants	96 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Pain, post Dose 3	12 Participants	20 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Redness, post Dose 3	61 Participants	51 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Redness, post Dose 3	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Swelling, post Dose 3	42 Participants	27 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Swelling, post Dose 3	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Swelling, post Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Pain, post Dose 2	137 Participants	139 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Pain, post Dose 2	29 Participants	43 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Redness, post Dose 2	54 Participants	63 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Redness, post Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Swelling, post Dose 2	48 Participants	34 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Swelling, post Dose 2	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within the 4-day (Days 0-3) post-booster vaccination period

Population: Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=156 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=153 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort Any Pain	100 Participants	83 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort Grade 3 Pain	24 Participants	18 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort Any Redness	59 Participants	60 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort Grade 3 Redness	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort Any Swelling	39 Participants	37 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort Grade 3 Swelling	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within the 4-day (Days 0-3) post-primary vaccination period following each dose

Population: Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented.

Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than \[≥\] 38.0 degrees Celsius \[°C\]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (\>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=198 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=197 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Drowsiness, post Dose 1	97 Participants	94 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Drowsiness, post Dose 1	12 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Related Drowsiness, post Dose 1	91 Participants	91 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Irr./Fuss., post Dose 1	129 Participants	122 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Irr./Fuss., post Dose 1	13 Participants	17 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Related Irr./Fuss., post Dose 1	123 Participants	115 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Loss Appet., post Dose 1	46 Participants	42 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Loss Appet., post Dose 1	3 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Related Loss Appet., post Dose 1	44 Participants	40 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Fever, post Dose 1	15 Participants	18 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Fever, post Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Drowsiness, post Dose 2	11 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Related Drowsiness, post Dose 2	81 Participants	90 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Irr./Fuss., post Dose 2	125 Participants	127 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Irr./Fuss., post Dose 2	19 Participants	25 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Loss Appet., post Dose 2	1 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Related Loss Appet., post Dose 2	43 Participants	46 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Fever, post Dose 2	17 Participants	23 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Fever, post Dose 2	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Related Fever, post Dose 2	14 Participants	14 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Related Drowsiness, post Dose 3	60 Participants	66 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Irr./Fuss., post Dose 3	101 Participants	96 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Related Irr./Fuss., post Dose 3	91 Participants	87 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Loss Appet., post Dose 3	45 Participants	39 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Loss Appet., post Dose 3	10 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Related Loss Appet., post Dose 3	40 Participants	36 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Fever, post Dose 3	10 Participants	18 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Fever, post Dose 3	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Related Fever, post Dose 3	8 Participants	11 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Related Fever, post Dose 1	10 Participants	10 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Drowsiness, post Dose 2	87 Participants	94 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Related Irr./Fuss., post Dose 2	117 Participants	117 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Loss Appet., post Dose 2	46 Participants	50 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Any Drowsiness, post Dose 3	64 Participants	72 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Drowsiness, post Dose 3	13 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort Grade 3 Irr./Fuss., post Dose 3	20 Participants	18 Participants

SECONDARY outcome

Timeframe: Within the 4-day (Days 0-3) post-booster vaccination period

Population: Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=156 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=154 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort Any Drowsiness	65 Participants	65 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort Grade 3 Drowsiness	13 Participants	12 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort Related Drowsiness	60 Participants	56 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort Any Irr./Fuss.	97 Participants	86 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort Grade 3 Irr./Fuss.	27 Participants	16 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort Any Loss Appet.	43 Participants	41 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort Related Irr./Fuss.	89 Participants	74 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort Grade 3 Loss Appet.	6 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort Related Loss Appet.	41 Participants	30 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort Any Fever	8 Participants	15 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort Grade 3 Fever	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort Related Fever	7 Participants	9 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) period post primary vaccination, across doses

Population: Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented.

An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno/reacto sub-cohort was composed of 200 vaccinated subjects from each study group.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=200 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=200 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Number of Subjects With Any Unsolicited Adverse Events (AEs) After Primary Vaccination - Immuno/Reacto Sub-cohort	114 Participants	114 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) period post booster vaccination

Population: Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented.

An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=178 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=174 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Number of Subjects With Any Unsolicited Adverse Events (AEs) After Booster Vaccination - Immuno/Reacto Sub-cohort	53 Participants	47 Participants

SECONDARY outcome

Timeframe: From Day 0 to Month 22

Population: Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.

An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.

Outcome measures

Outcome measures
Measure	dPly-PhtD Group n=900 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=903 Participants Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Number of Subjects With Any Serious Adverse Events (SAEs)	229 Participants	232 Participants

Adverse Events

dPly/PhtD Group

Serious events: 229 serious events

Other events: 191 other events

Deaths: 0 deaths

Control Group

Serious events: 232 serious events

Other events: 189 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	dPly/PhtD Group n=200 participants at risk；n=900 participants at risk Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.	Control Group n=200 participants at risk；n=903 participants at risk Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.
Infections and infestations Conjunctivitis	6.0% 12/200 • Number of events 13 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	5.5% 11/200 • Number of events 11 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
Respiratory, thoracic and mediastinal disorders Cough	7.0% 14/200 • Number of events 18 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	7.5% 15/200 • Number of events 17 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
Metabolism and nutrition disorders Decreased appetite	51.5% 103/200 • Number of events 180 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	49.0% 98/200 • Number of events 172 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
Skin and subcutaneous tissue disorders Dermatitis diaper	5.5% 11/200 • Number of events 12 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	2.5% 5/200 • Number of events 5 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
Gastrointestinal disorders Diarrhoea	6.0% 12/200 • Number of events 13 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	3.5% 7/200 • Number of events 8 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
Skin and subcutaneous tissue disorders Erythema	51.5% 103/200 • Number of events 235 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	54.5% 109/200 • Number of events 233 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
Psychiatric disorders Irritability	84.5% 169/200 • Number of events 458 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	83.0% 166/200 • Number of events 436 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
General disorders Pain	89.5% 179/200 • Number of events 482 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	87.5% 175/200 • Number of events 450 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
General disorders Pyrexia	43.5% 87/200 • Number of events 141 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	49.0% 98/200 • Number of events 170 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.5% 11/200 • Number of events 16 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	5.0% 10/200 • Number of events 12 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
Nervous system disorders Somnolence	67.5% 135/200 • Number of events 313 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	73.0% 146/200 • Number of events 325 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
General disorders Swelling	44.0% 88/200 • Number of events 164 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	40.5% 81/200 • Number of events 126 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
Gastrointestinal disorders Teething	6.0% 12/200 • Number of events 15 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	2.5% 5/200 • Number of events 6 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
Infections and infestations Upper respiratory tract infection	29.5% 59/200 • Number of events 74 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	25.0% 50/200 • Number of events 58 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
Infections and infestations Viral infection	11.0% 22/200 • Number of events 26 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).	7.5% 15/200 • Number of events 16 • Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).