Trial Outcomes & Findings for Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months. (NCT NCT00313911)

NCT ID: NCT00313911

Last Updated: 2014-04-21

Results Overview

High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2133 participants

Primary outcome timeframe

Day 0 up to Day 7 post-injection

Results posted on

2014-04-21

Participant Flow

Participants were enrolled and treated from 17 July 2006 to 02 January 2008 in 1 clinical center in Mexico and 1 clinical center in Peru.

A total of 2133 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Participant milestones

Participant milestones
Measure	DTaP-IPV-Hep B-PRP~T Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Tritanrix-Hep B/Hib™ + OPV Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
Overall Study STARTED	1422	711
Overall Study COMPLETED	1328	670
Overall Study NOT COMPLETED	94	41

Reasons for withdrawal

Reasons for withdrawal
Measure	DTaP-IPV-Hep B-PRP~T Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Tritanrix-Hep B/Hib™ + OPV Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
Overall Study Serious adverse event	6	1
Overall Study Adverse Event	2	3
Overall Study Protocol Violation	19	10
Overall Study Lost to Follow-up	27	14
Overall Study Withdrawal by Subject	39	12
Overall Study Did not meet age criteria	1	1

Baseline Characteristics

Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTaP-IPV-Hep B-PRP~T n=1422 Participants Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Tritanrix-Hep B/Hib™ + OPV n=711 Participants Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Total n=2133 Participants Total of all reporting groups
Age, Categorical <=18 years	1422 Participants n=5 Participants	711 Participants n=7 Participants	2133 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous Age Continuous	1.89 Months STANDARD_DEVIATION 0.195 • n=5 Participants	1.88 Months STANDARD_DEVIATION 0.197 • n=7 Participants	1.88 Months STANDARD_DEVIATION 0.196 • n=5 Participants
Sex: Female, Male Female	706 Participants n=5 Participants	344 Participants n=7 Participants	1050 Participants n=5 Participants
Sex: Female, Male Male	716 Participants n=5 Participants	367 Participants n=7 Participants	1083 Participants n=5 Participants
Region of Enrollment Mexico	712 Participants n=5 Participants	355 Participants n=7 Participants	1067 Participants n=5 Participants
Region of Enrollment Peru	710 Participants n=5 Participants	356 Participants n=7 Participants	1066 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 up to Day 7 post-injection

Population: The occurrence of high fever was assessed for all enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants in each group adjusted for the participant that got a vaccine assigned for the other group.

High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.

Outcome measures

Outcome measures
Measure	DTaP-IPV-Hep B-PRP~T n=1423 Participants Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Tritanrix-Hep B/Hib™ + OPV n=710 Participants Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. Post Dose 2 (N = 1348, 681)	25 Participants	15 Participants Interval 0.0 to 0.0
Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. Post Any Dose (N = 1411, 703)	56 Participants	39 Participants Interval 0.0 to 0.0
Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. Post Dose 1 (N = 1408, 703)	5 Participants	4 Participants Interval 0.0 to 0.0
Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. Post Dose 3 (N = 1328, 672)	26 Participants	23 Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 30 post-dose 3

Population: Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.

Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.

Outcome measures

Outcome measures
Measure	DTaP-IPV-Hep B-PRP~T n=184 Participants Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Tritanrix-Hep B/Hib™ + OPV n=95 Participants Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo	1075 Titers Interval 891.0 to 1298.0	3376 Titers Interval 2672.0 to 4338.0

SECONDARY outcome

Timeframe: Day 30 post-dose 3

Population: Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.

Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively.

Outcome measures

Outcome measures
Measure	DTaP-IPV-Hep B-PRP~T n=184 Participants Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Tritanrix-Hep B/Hib™ + OPV n=95 Participants Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo ≥ 10 mIU/mL	100 Percentage of Participants	100 Percentage of Participants Interval 0.0 to 0.0
Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo ≥ 100 mIU/mL	96 Percentage of Participants	99 Percentage of Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 0 up to Day 7 Post-injection

Population: Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants (N) in each group adjusted for the participant that got a vaccine assigned for the other group.

Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, \>3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable.

Outcome measures

Outcome measures
Measure	DTaP-IPV-Hep B-PRP~T n=1423 Participants Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Tritanrix-Hep B/Hib™ + OPV n=710 Participants Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Pyrexia Post Dose 1 (N=1408, 703)	538 Participants	473 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Pain Post Dose 3 (N=1327, 672)	519 Participants	448 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Swelling Post Dose 2 (N=1348, 681)	3 Participants	11 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Anorexia Post Dose 2 (N=1348, 681)	12 Participants	11 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Pain Post Dose 1 (N=1410, 703)	831 Participants	574 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Pain Post Dose 1 (N=1408, 703)	175 Participants	193 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Pain Post Dose 2 (N=1348, 681)	744 Participants	506 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Pain Post Dose 2 (N=1348, 681)	105 Participants	95 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Pain Post Dose 3 (N=1327, 672)	29 Participants	65 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Erythema Post Dose 1 (N=1408, 703)	245 Participants	234 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Erythema Post Dose 1 (N=1408, 703)	11 Participants	15 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Erythema Post Dose 2 (N=1348, 681)	427 Participants	308 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Erythema Post Dose 2 (N=1348, 681)	6 Participants	16 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Erythema Post Dose 3 (N=1327, 672)	587 Participants	340 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Erythema Post Dose 3 (N=1327, 672)	23 Participants	12 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Swelling Post Dose 1 (N=1406, 703)	151 Participants	188 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Swelling Post Dose 1 (N=1406, 703)	8 Participants	24 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Swelling Post Dose 2 (N=1348, 681)	259 Participants	270 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Swelling Post Dose 3 (N=1327, 672)	400 Participants	323 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Swelling Post Dose 3 (N=1327, 672)	3 Participants	7 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Pyrexia Post Dose 1 (N=1408, 703)	5 Participants	4 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Pyrexia Post Dose 2 (N=1348, 681)	675 Participants	457 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Pyrexia Post Dose 2 (N=1348, 681)	27 Participants	16 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Pyrexia Post Dose 3 (N=1328, 672)	552 Participants	445 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Pyrexia Post Dose 3 (N=1328, 672)	30 Participants	23 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Vomiting Post Dose 1 (N=1408, 703)	230 Participants	120 Participants
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Vomiting Post Dose 1 (N=1408, 703)	10 Participants	4 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Vomiting Post Dose 2 (N=1348, 681)	152 Participants	75 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Vomiting Post Dose 2 (N=1348, 681)	2 Participants	4 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Vomiting Post Dose 3 (N=1328, 672)	167 Participants	95 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Vomiting Post Dose 3 (N=1328, 672)	17 Participants	10 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Crying Post Dose 1 (N=1409, 703)	800 Participants	564 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Crying Post Dose 1 (N=1409, 703)	21 Participants	26 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Crying Post Dose 2 (N=1348, 681)	721 Participants	481 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Crying Post Dose 2 (N=1348, 681)	9 Participants	8 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Crying Post Dose 3 (N=1327, 672)	466 Participants	391 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Crying Post Dose 3 (N=1327, 672)	9 Participants	8 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Somnolence Post Dose 1 (N=1408, 703)	635 Participants	375 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Somnolence Post Dose 1 (N=1408, 703)	46 Participants	26 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Somnolence Post Dose 2 (N=1348, 681)	405 Participants	247 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Somnolence Post Dose 2 (N=1348, 681)	16 Participants	12 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Somnolence Post Dose 3 (N=1327, 672)	272 Participants	204 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Somnolence Post Dose 3 (N=1327, 672)	12 Participants	11 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Anorexia Post Dose 1 (N=1408, 703)	388 Participants	278 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Anorexia Post Dose 1 (N=1408, 703)	11 Participants	14 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Anorexia Post Dose 2 (N=1348, 681)	327 Participants	195 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Anorexia Post Dose 3 (N=1327, 672)	294 Participants	189 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Anorexia Post Dose 3 (N=1327, 672)	18 Participants	17 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Irritability Post Dose 1 (N=1408, 703)	945 Participants	576 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Irritability Post Dose 1 (N=1408, 703)	42 Participants	47 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Irritability Post Dose 2 (N=1348, 681)	799 Participants	492 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Irritability Post Dose 2 (N=1348, 681)	41 Participants	25 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Any Irritability Post Dose 3 (N=1327, 672)	546 Participants	416 Participants Interval 0.0 to 0.0
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination Severe Irritability Post Dose 3 (N=1327, 672)	11 Participants	17 Participants Interval 0.0 to 0.0

Adverse Events

DTaP-IPV-Hep B-PRP~T

Serious events: 91 serious events

Other events: 945 other events

Deaths: 0 deaths

Tritanrix-Hep B/Hib™ + OPV

Serious events: 46 serious events

Other events: 576 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Publication restrictions are in place

Restriction type: OTHER

Measure	DTaP-IPV-Hep B-PRP~T n=1423 participants at risk Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Tritanrix-Hep B/Hib™ + OPV n=710 participants at risk Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
Infections and infestations Rhinitis	9.6% 136/1411 • Number of events 136 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	8.0% 56/703 • Number of events 56 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
Gastrointestinal disorders Abdominal Pain	9.3% 131/1411 • Number of events 131 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	10.0% 70/703 • Number of events 70 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
Gastrointestinal disorders Diarrhoea	18.7% 264/1411 • Number of events 264 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	17.5% 123/703 • Number of events 123 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
Gastrointestinal disorders Solicited Vomiting Post-dose 1	16.3% 230/1410 • Number of events 230 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	17.1% 120/703 • Number of events 120 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
General disorders Solicited Injection site Erythema Post-dose 3	41.6% 587/1410 • Number of events 587 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	48.4% 340/703 • Number of events 340 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
General disorders Injection Site Haemorrhage	2.8% 39/1411 • Number of events 39 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	9.0% 63/703 • Number of events 63 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
General disorders Injection Site Nodule	5.7% 81/1411 • Number of events 81 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	11.2% 79/703 • Number of events 79 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
General disorders Solicited Injection Site Pain Post-dose 1	58.9% 831/1410 • Number of events 831 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	81.7% 574/703 • Number of events 574 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
General disorders Solicited Injection Site Swelling Post-dose 3	28.4% 400/1408 • Number of events 400 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	45.9% 323/703 • Number of events 323 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
General disorders Solicited Irritability post-dose 1	67.0% 945/1410 • Number of events 945 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	81.9% 576/703 • Number of events 576 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
General disorders Solicited Pyrexia Post-dose 2	47.8% 675/1411 • Number of events 675 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	65.0% 457/703 • Number of events 457 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
Infections and infestations Gastroenteritis	7.2% 101/1411 • Number of events 101 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	5.7% 40/703 • Number of events 40 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
Infections and infestations Nasopharyngitis	52.6% 742/1411 • Number of events 742 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	50.2% 353/703 • Number of events 353 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
Infections and infestations Pharyngitis	28.0% 395/1411 • Number of events 395 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	22.9% 161/703 • Number of events 161 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
Metabolism and nutrition disorders Solicited Anorexia Post-dose 1	27.5% 388/1410 • Number of events 388 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	39.5% 278/703 • Number of events 278 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
Nervous system disorders Solicited Somnolence Post-dose 1	45.0% 635/1410 • Number of events 635 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	53.3% 375/703 • Number of events 375 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
Psychiatric disorders Solicited Crying Post-dose 1	56.7% 800/1411 • Number of events 800 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	80.2% 564/703 • Number of events 564 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
Respiratory, thoracic and mediastinal disorders Bronchospasm	11.6% 163/1411 • Number of events 163 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	10.5% 74/703 • Number of events 74 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	5.3% 75/1411 • Number of events 75 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	5.1% 36/703 • Number of events 36 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
Skin and subcutaneous tissue disorders Dermatitis Diaper	11.3% 160/1411 • Number of events 160 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.	7.7% 54/703 • Number of events 54 • Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.