Trial Outcomes & Findings for A Study of Influenza Virus Vaccines in Children and Adults (NCT NCT00988143)

Last Updated: 2013-12-12

Results Overview

Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: \>103.1°F; Abnormal crying: \>3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable. (24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: \>102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity. (Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering. Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: \>10 cm; Fever \>102.1°F; Headache, Malaise, Myalgia \& Shivering: Significant, prevents daily activity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

600 participants

Primary outcome timeframe

Day 0 up to 7 days post-vaccination

Results posted on

2013-12-12

Participant Flow

The study participants were enrolled from 01 October through 05 November 2009 in 4 clinical centers in the US.

A total of 600 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.

Participant milestones

Participant milestones
Measure	Study Group 1 (2009-2010 TIV) Participants received the 2009-2010 Trivalent Influenza Vaccine (Pediatric dose with no preservatives)	Study Group 2 (2008-2009 TIV) Participants received the 2008-2009 Trivalent Influenza Vaccine	Study Group 3 (QIV) Participants received the Quadrivalent Influenza Vaccine
Overall Study STARTED	220	190	190
Overall Study COMPLETED	220	190	190
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Influenza Virus Vaccines in Children and Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n=220 Participants Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n=190 Participants Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)	Study Group 3 (Quadrivalent Influenza Vaccine) n=190 Participants Participants received the Quadrivalent Influenza Vaccine (QIV)	Total n=600 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	30 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	127 Participants n=93 Participants	135 Participants n=4 Participants	123 Participants n=27 Participants	385 Participants n=483 Participants
Age, Categorical >=65 years	63 Participants n=93 Participants	55 Participants n=4 Participants	67 Participants n=27 Participants	185 Participants n=483 Participants
Age Continuous	47.8 Years STANDARD_DEVIATION 24.9 • n=93 Participants	54.9 Years STANDARD_DEVIATION 17.5 • n=4 Participants	56.7 Years STANDARD_DEVIATION 17.2 • n=27 Participants	52.9 Years STANDARD_DEVIATION 20.8 • n=483 Participants
Sex: Female, Male Female	144 Participants n=93 Participants	124 Participants n=4 Participants	130 Participants n=27 Participants	398 Participants n=483 Participants
Sex: Female, Male Male	76 Participants n=93 Participants	66 Participants n=4 Participants	60 Participants n=27 Participants	202 Participants n=483 Participants
Region of Enrollment United States	220 Participants n=93 Participants	190 Participants n=4 Participants	190 Participants n=27 Participants	600 Participants n=483 Participants

PRIMARY outcome

Timeframe: Day 0 up to 7 days post-vaccination

Population: Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.

Outcome measures

PRIMARY outcome

Timeframe: 21 Days post last vaccination

Population: Geometric mean titers to vaccine B strains were determined in randomized and vaccinated participants, per-protocol population

Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.

Outcome measures

Outcome measures
Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n=187 Participants Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n=188 Participants Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)	Study Group 3 (Quadrivalent Influenza Vaccine) n=190 Participants Participants received the Quadrivalent Influenza Vaccine (QIV)
Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. B/Brisbane/60/2008 (187, 0, 190)	114 Titers Interval 97.8 to 134.0	NA Titers B/Brisbane influenza virus antigen not in the vaccine administered to this group	101 Titers Interval 85.6 to 120.0
Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. B/Florida/04/2006 (0, 188, 190)	NA Titers B/Florida influenza virus antigen not in the vaccine administered to this group	135 Titers Interval 117.0 to 156.0	155 Titers Interval 133.0 to 180.0

PRIMARY outcome

Timeframe: 21 Days post last vaccination

Population: Geometric mean titers to vaccine A strains were determined in the per-protocol population. For this outcome, the data for the A/Brisbane/59/2007(A1N1) and A/Uruguay/716/2007(H3N2) antibodies were pooled for participants vaccinated with either 2009-2010 TIV or 2008-2009 TIV and presented in the column for Study Group 1 (2009-2010 TIV).

Outcome measures

Outcome measures
Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n=375 Participants Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)	Study Group 3 (Quadrivalent Influenza Vaccine) n=190 Participants Participants received the Quadrivalent Influenza Vaccine (QIV)
Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. A/Brisbane/59/2007(A1N1) [N = 375, 0, 190]	151 Titers Interval 134.0 to 171.0	—	161 Titers Interval 137.0 to 189.0
Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants. A/Uruguay/716/2007(H3N2) [N = 375, 0, 190]	339 Titers Interval 239.0 to 392.0	—	304 Titers Interval 249.0 to 370.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (pre-vaccination) and Day 21 post final vaccination

Population: Seroprotection against the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)

Outcome measures

Outcome measures
Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n=187 Participants Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n=188 Participants Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)	Study Group 3 (Quadrivalent Influenza Vaccine) n=190 Participants Participants received the Quadrivalent Influenza Vaccine (QIV)
Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine A/H1N1, Pre-vaccination (186, 188, 190)	84 Participants	77 Participants Interval 23.1 to 33.6	81 Participants Interval 0.0 to 0.0
Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine A/H1N1, Post-vaccination (187, 188, 190)	168 Participants	173 Participants Interval 123.0 to 172.0	176 Participants Interval 0.0 to 0.0
Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine A/H3N2, Pre-vaccination (186, 187, 190)	83 Participants	91 Participants Interval 27.7 to 43.3	93 Participants Interval 0.0 to 0.0
Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine A/H3N2, Post-vaccination (187, 188, 190)	180 Participants	177 Participants Interval 271.0 to 401.0	180 Participants Interval 0.0 to 0.0
Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine B/Brisbane/60/2008, Pre-vaccination (186, 0, 190)	80 Participants	NA Participants Interval 0.0 to 0.0 B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group.	69 Participants Interval 0.0 to 0.0
Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine B/Brisbane/60/2008, Post-vaccination (187, 0, 190)	168 Participants	NA Participants Interval 0.0 to 0.0 B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group.	162 Participants Interval 0.0 to 0.0
Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine B/Florida/04/2006, Pre-vaccination (0, 187, 190)	NA Participants B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group.	97 Participants Interval 22.8 to 31.1	89 Participants Interval 0.0 to 0.0
Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine B/Florida/04/2006, Post-vaccination (0, 187, 190)	NA Participants B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group.	174 Participants Interval 84.0 to 111.0	175 Participants Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 21 Days post last vaccination

Population: Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population

Outcome measures

Outcome measures
Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n=187 Participants Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n=188 Participants Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)	Study Group 3 (Quadrivalent Influenza Vaccine) n=190 Participants Participants received the Quadrivalent Influenza Vaccine (QIV)
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants A/H1N1, Pre-vaccination (186, 188, 190)	27.5 Titers Interval 22.8 to 33.0	28.4 Titers Interval 23.6 to 34.3	27.6 Titers Interval 22.7 to 33.6
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants A/H1N1, Post-vaccination (187, 188, 190)	145 Titers Interval 122.0 to 173.0	157 Titers Interval 132.0 to 187.0	161 Titers Interval 137.0 to 189.0
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants A/H3N2, Pre-vaccination (186, 188, 190)	29.9 Titers Interval 24.0 to 37.2	32.7 Titers Interval 25.8 to 41.6	38.5 Titers Interval 29.7 to 49.9
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants A/H3N2, Post-vaccination (187, 188, 190)	302 Titers Interval 250.0 to 365.0	380 Titers Interval 305.0 to 472.0	304 Titers Interval 249.0 to 370.0
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants B/Brisbane/60/2008, Pre-vaccination (186, 0, 190)	22.0 Titers Interval 18.5 to 26.2	NA Titers B/Brisbane/60/2008 influenza virus antigen not in the vaccine administered to this group.	19.9 Titers Interval 16.7 to 23.7
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants B/Brisbane/60/2008, Post-vaccination (187, 0, 190)	114 Titers Interval 97.8 to 134.0	NA Titers B/Brisbane/60/2008 influenza virus antigen not in the vaccine administered to this group.	101 Titers Interval 85.6 to 120.0
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants B/Florida/04/2006, Pre-vaccination (0, 187, 190)	NA Titers B/Florida/04/2006 influenza virus antigen not in the vaccine administered to this group.	32.6 Titers Interval 27.4 to 38.7	27.1 Titers Interval 22.5 to 32.6
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants B/Florida/04/2006, Post-vaccination (0, 187, 190)	NA Titers B/Florida/04/2006 influenza virus antigen not in the vaccine administered to this group.	135 Titers Interval 117.0 to 156.0	155 Titers Interval 133.0 to 180.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 21 post-vaccination

Population: Seroconversion with respect to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.

Seroconversion to vaccine antigens was defined as a pre-vaccination titer \< 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.

Outcome measures

Outcome measures
Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n=187 Participants Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n=188 Participants Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)	Study Group 3 (Quadrivalent Influenza Vaccine) n=190 Participants Participants received the Quadrivalent Influenza Vaccine (QIV)
Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines A/H1N1 (187, 188, 190)	103 Participants	97 Participants Interval 0.0 to 0.0	112 Participants Interval 0.0 to 0.0
Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines A/H3N2 (187, 188, 190)	130 Participants	120 Participants Interval 0.0 to 0.0	119 Participants Interval 0.0 to 0.0
Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines B/Brisbane/60/2008 (187, 0, 190)	104 Participants	NA Participants Interval 0.0 to 0.0 B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group.	101 Participants Interval 0.0 to 0.0
Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines B/Florida/04/2006 (0, 188, 190)	NA Participants B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group.	83 Participants Interval 0.0 to 0.0	110 Participants Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 21 Days post last vaccination

Population: Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population

Outcome measures

Outcome measures
Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n=215 Participants Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n=188 Participants Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)	Study Group 3 (Quadrivalent Influenza Vaccine) n=189 Participants Participants received the Quadrivalent Influenza Vaccine (QIV)
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants A/H1N1, Pre-vaccination (214, 186, 189)	27.0 Titers Interval 22.8 to 32.1	27.8 Titers Interval 23.1 to 33.6	25.4 Titers Interval 21.0 to 30.8
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants A/H1N1, Post-vaccination (214, 187, 189)	153 Titers Interval 131.0 to 179.0	145 Titers Interval 123.0 to 172.0	143 Titers Interval 122.0 to 168.0
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants A/H3N2, Pre-vaccination (214, 187, 189)	30.5 Titers Interval 25.1 to 37.2	34.6 Titers Interval 27.7 to 43.3	37.8 Titers Interval 29.8 to 47.9
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants A/H3N2, Post-vaccination (214, 188, 189)	285 Titers Interval 244.0 to 334.0	330 Titers Interval 271.0 to 401.0	263 Titers Interval 219.0 to 316.0
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants B/Brisbane/60/2008, Pre-vaccination (214, 0, 189)	15.5 Titers Interval 13.4 to 18.0	NA Titers B/Brisbane/60/2008 influenza virus antigen was not in vaccine administered to this group.	16.2 Titers Interval 13.9 to 18.8
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants B/Brisbane/60/2008, Post-vaccination (215, 0, 189)	76.7 Titers Interval 66.6 to 88.4	NA Titers B/Brisbane/60/2008 influenza virus antigen was not in vaccine administered to this group.	75.6 Titers Interval 64.8 to 88.2
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants B/Florida/04/2006, Pre-vaccination (0, 186, 189)	NA Titers B/Florida/04/2006 influenza virus antigen was not in vaccine administered to this group.	26.6 Titers Interval 22.8 to 31.1	21.7 Titers Interval 18.3 to 25.7
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants B/Florida/04/2006, Post-vaccination (0, 187, 189)	NA Titers B/Florida/04/2006 influenza virus antigen was not in vaccine administered to this group.	96.5 Titers Interval 84.0 to 111.0	109 Titers Interval 94.5 to 125.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 up to 21 days post-vaccination

Population: Seroconversion with respects to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population

Seroconversion to vaccine antigens were defined as a pre-vaccination titer \< 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.

Outcome measures

Outcome measures
Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n=215 Participants Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n=188 Participants Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)	Study Group 3 (Quadrivalent Influenza Vaccine) n=189 Participants Participants received the Quadrivalent Influenza Vaccine (QIV)
Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines A/H1N1 Pre-vaccination (214, 186, 189)	88 Participants	71 Participants	70 Participants
Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines A/H1N1 Post-vaccination (213, 186, 189)	118 Participants	90 Participants	112 Participants
Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines A/H3N2 Pre-vaccination (214, 187, 189)	100 Participants	94 Participants	92 Participants
Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines A/H3N2 Post-vaccination (213, 187, 189)	148 Participants	119 Participants	116 Participants
Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines B/Brisbane/60/2008 Pre-vaccination (214, 0, 189)	57 Participants	NA Participants B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group.	50 Participants
Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines B/Brisbane/60/2008 Post-vaccination (214, 0, 189)	111 Participants	NA Participants B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group.	99 Participants
Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines B/Florida/04/2006 Pre-vaccination (0, 186, 189)	NA Participants B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group.	80 Participants	67 Participants
Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines B/Florida/04/2006 Post-vaccination (0, 186, 189)	NA Participants B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group	79 Participants	100 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 (pre-vaccination) and Day 21 post final vaccination

Population: Seroprotection to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population

Outcome measures

Outcome measures
Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n=215 Participants Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n=188 Participants Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)	Study Group 3 (Quadrivalent Influenza Vaccine) n=189 Participants Participants received the Quadrivalent Influenza Vaccine (QIV)
Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines A/H1N1, Pre-vaccination (214, 186, 189)	88 Participants	71 Participants	70 Participants
Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines A/H1N1, Post-vaccination (214, 187, 189)	193 Participants	168 Participants	169 Participants
Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines A/H3N2, Pre-vaccination (214, 187, 189)	100 Participants	94 Participants	92 Participants
Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines A/H3N2, Post-vaccination (214, 188, 189)	209 Participants	179 Participants	179 Participants
Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines B/Brisbane/60/2008, Pre-vaccination (214, 0, 189)	57 Participants	NA Participants B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group.	50 Participants
Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines B/Brisbane/60/2008, Post-vaccination (215, 0, 189)	172 Participants	NA Participants B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group.	153 Participants
Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines B/Florida/04/2006, Pre-vaccination (0, 186, 189)	NA Participants B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group.	80 Participants	67 Participants
Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines B/Florida/04/2006, Post-vaccination (0, 187, 189)	NA Participants B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group.	164 Participants	169 Participants

Adverse Events

Study Group 1 (2009-2010 Trivalent Influenza Vaccine)

Serious events: 0 serious events

Other events: 105 other events

Deaths: 0 deaths

Study Group 2 (2008-2009 Trivalent Influenza Vaccine)

Serious events: 0 serious events

Other events: 84 other events

Deaths: 0 deaths

Study Group 3 (Quadrivalent Influenza Vaccine)

Serious events: 2 serious events

Other events: 91 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n=220 participants at risk Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n=190 participants at risk Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)	Study Group 3 (Quadrivalent Influenza Vaccine) n=190 participants at risk Participants received the Quadrivalent Influenza Vaccine (QIV)
Ear and labyrinth disorders Vertigo positional	0.00% 0/220 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	0.53% 1/190 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
General disorders Chest pain	0.00% 0/220 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	0.53% 1/190 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination

Other adverse events

Other adverse events
Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n=220 participants at risk Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n=190 participants at risk Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)	Study Group 3 (Quadrivalent Influenza Vaccine) n=190 participants at risk Participants received the Quadrivalent Influenza Vaccine (QIV)
Gastrointestinal disorders Pyrexia	6.7% 2/30 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
Respiratory, thoracic and mediastinal disorders Cough	10.0% 3/30 • Number of events 3 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	20.0% 6/30 • Number of events 6 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
Skin and subcutaneous tissue disorders Rash	6.7% 2/30 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
Nervous system disorders Headache	15.9% 35/220 • Number of events 35 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	17.9% 34/190 • Number of events 34 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	15.8% 30/190 • Number of events 30 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
General disorders Injection site Pain	48.8% 105/215 • Number of events 105 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	43.2% 82/190 • Number of events 82 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	47.4% 90/190 • Number of events 90 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
Metabolism and nutrition disorders Appetite lost	6.7% 1/15 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
Nervous system disorders Drowsiness	26.7% 4/15 • Number of events 4 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
Psychiatric disorders Crying abnormal	6.7% 1/15 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
Psychiatric disorders Irritability	6.7% 1/15 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	— 0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
General disorders Malaise	13.6% 30/220 • Number of events 30 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	12.1% 23/190 • Number of events 23 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	10.5% 20/190 • Number of events 20 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
Musculoskeletal and connective tissue disorders Myalgia	22.7% 50/220 • Number of events 50 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	16.8% 32/190 • Number of events 32 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	23.7% 45/190 • Number of events 45 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
General disorders Shivering	5.3% 10/190 • Number of events 10 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	3.2% 6/190 • Number of events 6 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination	2.6% 5/190 • Number of events 5 • Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination

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	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n=220 Participants Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n=190 Participants Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)	Study Group 3 (Quadrivalent Influenza Vaccine) n=190 Participants Participants received the Quadrivalent Influenza Vaccine (QIV)
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Injection site Tenderness (15, 0, 0)	4 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Injection site Tenderness (15, 0, 0)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Injection site Pain (205, 190, 190)	105 Participants	82 Participants Interval 0.0 to 0.0	90 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Injection site Pain (206, 190, 190)	1 Participants	0 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Injection site Erythema (220, 190, 190)	7 Participants	3 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Injection site Erythema (220, 190, 190)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Injection site Swelling (220, 190, 190)	10 Participants	2 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Injection site Swelling (220, 190, 190)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Injection site Induration (190, 190, 190)	3 Participants	1 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Injection site Induration (190, 190, 190)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Injection site Ecchymosis (190, 190, 190)	1 Participants	1 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Injection site Ecchymosis (190, 190, 190)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Fever (220, 190, 190)	2 Participants	1 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Fever (220, 190, 190)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Vomiting (15, 0, 0)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Vomiting (15, 0, 0)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Malaise (205, 190, 190)	30 Participants	23 Participants Interval 0.0 to 0.0	20 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Malaise (205, 190, 190)	3 Participants	1 Participants Interval 0.0 to 0.0	2 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Appetite lost (15, 0, 0)	1 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Appetite lost (15, 0, 0)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Drowsiness (15, 0, 0)	4 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Drowsiness (15, 0, 0)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Crying abnormal (15, 0, 0)	1 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Crying abnormal (15, 0, 0)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Headache (205, 189, 190)	35 Participants	34 Participants Interval 0.0 to 0.0	30 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Headache (205, 189, 190)	1 Participants	0 Participants Interval 0.0 to 0.0	1 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Irritability (15, 0, 0)	5 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Irritability (15, 0, 0)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Myalgia (205, 190, 190)	50 Participants	32 Participants Interval 0.0 to 0.0	45 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Myalgia (205, 190, 190)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Shivering (190, 190, 190)	10 Participants	6 Participants Interval 0.0 to 0.0	5 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. Grade 3 Shivering (190, 190, 190)	0 Participants	0 Participants Interval 0.0 to 0.0	0 Participants Interval 0.0 to 0.0