Page 1 of 33

Example Individual Study Summaries 

Efficacy Studies

Example 1: BVD PI calf study

Example 2: shedding/culture study for Leptospira 

Example 3: lymphoid pathology study for porcine circovirus 

Example 4: mortality/clinical signs for Haemophilus parasuis

Example 5: lung lesion scores for Mycoplasma hyopneumoniae 

Example 6: placeholder for study data no longer on file 

Example 7: temperatures and other signs for IBR respiratory study 

Example 8: passive immunity/pig litters for E coli

Example 9: clinical signs for feline calicivirus

Example 13: 9CFR Marek’s disease study

Example 17: placeholder for study submitted to USDA-APHIS prior to January 1, 2007 

Example 18: placeholder for influenza strain swap, per VSM 800.111, that did not require 

vaccination-challenge

Example 19: placeholder for conditionally licensed platform product, per VSM 800.213, that did 

not require vaccination-challenge 

Example 20: placeholder for prescription platform product, per VSM 800.214

Safety Studies

Example 10: field safety (typical study design) 

Example 11: field safety (reproductive health, single offspring) 

Example 12: field safety (reproductive health, litter offspring) 

Example 14: field safety—poultry 

Example 15: field safety—with events affirmed by licensee to have cause other than vaccination 

Example 16: field safety—with explanatory note 
Page 2 of 33

Highlighted sections are OPTIONAL. All other data elements are required.

Updated: April 8, 2020
Page 3 of 33

Example 1: 

Study Type Efficacy

Pertaining to Bovine Virus Diarrhea Virus, Type 1 (BVDV1)

Study Purpose Demonstrate effectiveness in pregnant animals against 

persistently infected calves

Product Administration One dose administered subcutaneously one month prior to 

breeding.

Study Animals 20 vaccinated and 19 control Angus crossbred heifers, 16-18 

months of age at first vaccination, seronegative (titer >2) to 

BVDV1 and BVDV2. 

Challenge Description BVDV1a Singer strain administered 230 days after vaccination 

(~169-194 days of gestation) 

Observation interval 

after last treatment

Calves examined 50 days after challenge

Results An animal was considered affected by the challenge if the calf

had a BVDV serum neutralizing antibody titer ≥2 OR BVDV 

could be isolated from the calf. 

19/19 controls and 6/20 vaccinates were affected. 

Control 

ID

Virus Antibody Vacc 

ID

Virus Antibody

1 + <2 1 - <2

2 + <2 2 - <2

3 + <2 3 + <2

4 + <2 4 - <2

5 + <2 5 - <2

6 + <2 6 - 8

7 + <2 7 - <2

8 + <2 8 + <2

9 + <2 9 - <2

10 + <2 10 - <2

11 + <2 11 - <2

12 + <2 12 - <2

13 + <2 13 + <2

14 + <2 14 + <2

15 + <2 15 - <2

16 + <2 16 - <2

17 + <2 17 - <2

18 + <2 18 - 32

19 + <2 19 - <2

20 - <2

USDA Approval Date mm/dd/yyyy
Page 4 of 33

Example 2: 

Study Type Efficacy 

Pertaining to Leptospira pomona

Study Purpose Pivotal efficacy against leptospirosis due to L. pomona

Product Administration Two doses were administered subcutaneously (SC) or 

intramuscular (IM) at 21-day intervals.

Study Animals 3-month old calves were vaccinated twice (SC or IM) 21 days

apart . Animals were seronegative to leptospiral serovars

canicola, grippotyphosa, hardjo, icterohaemorrhagiae, and

pomona. Twelve animals each were vaccinated by the SC and IM

route; 12 animals served as controls.

Challenge Description All animals were challenged with L. pomona 14 days after the 

last vaccination.

Observation interval 

after last treatment

Urine cultures were collected every two days for 10 days. 

Kidney and liver cultures were performed 14 days after 

challenge.

Results Animals are considered affected by challenge if L. pomona could 

be recovered from any of the urine cultures or tissue cultures.

Urine Culture Results: 

Controls: 8/12 (66.7%) positive 

IM Vaccinates: 0/12 (0%) 

SC Vaccinates: 0/12 (0%)

Urine Culture Data

Control 

ID

Day 2 Day 4 Day 6 Day 8 Day 10

1 - - - - -

2 - + + + +

3 - + + - -

4 - + - + -

5 + + + + +

6 + + + + -

7 - - - - -

8 - - - - -

9 - + + - -

10 - + + + +

11 + + - - -

12 - + + - +

All vaccinates were negative at all sampling points

Three controls had positive kidney samples; none of the animals 

had positive liver samples.

USDA Approval Date mm/dd/yyyy
Page 5 of 33

Example 3: 

Study Type Efficacy 

Pertaining to Circovirus, Porcine, Type 2 (PCV2)

Study Purpose Pivotal efficacy against porcine circovirus-associated disease

Product Administration One dose administered intramuscularly 

Study Animals Caesarian-derived, colostrum deprived piglets randomly divided 

into 20 vaccinates and 20 controls. Piglets were 12 days of age at 

the time of vaccination. 

Challenge Description All pigs were challenged 31 days after vaccination with PCV2a. 

Observation interval 

after last treatment

Lymphoid tissues examined 34 days after challenge

Results Pigs were evaluated for the presence of PCV2 in lymphoid 

tissues, and pathologic changes in lymph nodes (lymphoid 

depletion). Tissues examined included tracheobronchial, 

mesenteric and sub-iliac lymph nodes, as well as the tonsil.

Results: PCV2 was recovered from lymphoid tissues of 3/20 

vaccinates and 17/20 control piglets. Lymphoid depletion was 

observed in lymph nodes of 3/20 vaccinates and 16/20 controls. 

Control 

ID

Virus Lymphoid 

Depletion

Vacc 

ID

Virus Lymphoid 

Depletion

1 + + 1 - -

2 + + 2 - -

3 - - 3 + +

4 + + 4 - -

5 + + 5 - -

6 + + 6 - -

7 + + 7 - -

8 + + 8 + +

9 + + 9 - -

10 - - 10 - -

11 + + 11 - -

12 - - 12 - -

13 + + 13 + +

14 + + 14 - -

15 + + 15 - -

16 + + 16 - -

17 + + 17 - -

18 + + 18 - -

19 + + 19 - -

20 + - 20 - -

USDA Approval Date mm/dd/yyyy
Page 6 of 33

Example 4: 

Study Type Efficacy 

Pertaining to Haemophilus parasuis

Study Purpose Efficacy against Glasser’s disease

Product Administration One dose administered intramuscularly

Study Animals 3-week old pigs randomly divided into 21 vaccinates and 20

controls.

Challenge Description All pigs were challenged 21 days after vaccination with H. 

parasuis

Observation interval 

after last treatment

Observed daily for 21 days

Results Results:

 Mortality after Challenge

Vaccinates 5/18

Controls 13/20

Clinical Signs of Glasser’s Disease after Challenge

Vaccinate Control

Arthritis 4 of 18 5 of 20

Pneumonia 3 6

Pericarditis 0 2

Pleuritis 0 6

Control Animals

ID Arthritis Pneumonia Pericarditis Pleuritis Death

1 Yes No No No Yes

2 No Yes No Yes Yes

3 No No No No No

4 Yes Yes Yes Yes Yes

5 No No No No No

6 No No No No No

7 No No No No Yes

8 No Yes Yes Yes Yes

9 Yes No No No No

10 No No No No Yes

11 No No No No Yes

12 No Yes Yes Yes Yes

13 No No No No Yes

14 Yes No No No No

15 No Yes No Yes Yes

16 No No No No No

17 No No No No No

18 Yes Yes Yes Yes Yes

19 No No No No Yes

20 No No No No Yes
Page 7 of 33

Vaccinated Animals

ID Arthritis Pneumonia Pericarditis Pleuritis Death

1 No No No No No

2 Yes No No No No

3 No No No No Yes

4 No Yes No No Yes

5 No No No No No

6 Yes No No No No

7 No No No No No

8 No Yes No No Yes

9 No No No No No

10 No No No No No

11 No No No No No

12 No No No No No

13 No No No No No

14 Yes No No No Yes

15 Yes No No No No

16 No No No No No

17 No No No No No

18 No No No No No

19 No Yes No No Yes

USDA Approval Date mm/dd/yyyy
Page 8 of 33

Example 5: 

Study Type Efficacy

Pertaining to Mycoplasma hyopneumoniae

Study Purpose Efficacy against respiratory disease

Product 

Administration (# doses, 

route of administration, 

interval between doses)

2 doses, given intramuscularly, 2 weeks apart

Study Animals (species, 

age at first product 

administration, number per 

treatment group)

Commercial pigs, 3 weeks of age. 32 vaccinates and 31 controls

Challenge Description 

(agent, route of 

administration, interval 

between last product dose and 

challenge)

Mycoplasma hyopneumoniae, given 3 weeks after final 

vaccination

Interval observed after 

challenge

Lungs evaluated 4 weeks after challenge

Results The percent of the lung mass that was abnormal (consolidated) 

was calculated for every animal. 

5-number summary for lung consolidation (%)

Treatment Minimum Q1 Median Q3 Maximum

Controls 4.4 7.5 13.2 18.0 26.3

Vaccinates 0.0 2.0 5.3 10.5 20.8

Raw data shown on attached page. 

USDA Approval Date mm/dd/yyyy
Page 9 of 33

Lung consolidation scores (%), in order of rank:

Vaccinate Control

0.1 0

0.1 0.3

0.1 1.0

0.1 2.3

0.1 2.5

0.2 3.0

0.3 3.1

0.3 4.5

0.3 6.7

0.5 8.2

0.5 8.2

0.6 10.8

0.7 11.0

1.1 11.3

1.3 12.1

1.8 12.5

1.9 14.1

2.0 14.8

5.3 15.1

5.7 18.0

10.2 20.1

10.7 23.2

10.9 24.8

33.3 35.0
Page 10 of 33

Example 6: 

Study Type Efficacy

Pertaining to Herpesvirus, Bovine (IBR)

Study Purpose Efficacy against respiratory disease

Product Administration 

Study Animals 

Challenge Description 

Interval observed after 

challenge

Results Study data were evaluated by USDA-APHIS prior to product 

licensure and met regulatory standards for acceptance at the time 

of submission. Study data, however, are no longer available.

USDA Approval Date May 21, 1962
Page 11 of 33

Example 7: 

Study Type Efficacy

Pertaining to Herpesvirus, bovine (IBR)

Study Purpose Demonstrate effectiveness against infectious bovine 

rhinotracheitis

Product Administration Single dose, administered subcutaneously

Study Animals Forty calves, seronegative to IBR, 3 months of age, 20 

vaccinates and 20 controls 

Challenge Description IBR virus administered 14 days after vaccination

Interval observed after 

challenge

Calves observed daily for 14 days after challenge

Results Animals were considered affected by the challenge if they had a 

temperature ≥104.0 on more than one day AND demonstrated at 

least one clinical sign (depression, dyspnea, or purulent nasal 

discharge) on at least one day. 

Totals:

16/18 controls affected 

0/17 vaccinates affected

Raw data:

See attached.

USDA Approval Date mm/dd/yyyy
Page 12 of 33
Page 13 of 33

Clinical Sign Data:

Vaccinates

Controls

Key to nasal discharge score:

0=normal 

1=serous discharge 

2=purulent discharge
Page 14 of 33

Example 8: 

Study Type Efficacy

Pertaining to Escherichia coli

Study Purpose Efficacy against neonatal diarrhea due to K99 pilus-expressing E 

coli

Product Administration 2 doses, administered intramuscularly to pregnant gilts, 

approximately 5 and 2 weeks prior to farrowing

Study Animals Crossbred commercial gilts, 6 months of age at breeding. 20 

vaccinated gilts and 10 control gilts. Healthy piglets in each 

litter were challenged.

Challenge Description K99+ E coli given to neonatal piglets 2 hours after first nursing 

(colostrum)

Interval observed after 

challenge

Observed daily for 7 days after challenge

Results Mortality in each litter was assessed. 

Total pigs dead: 

From vaccinated sows: 21/150 (14%) 

From control sows: 48/67 (72%) 

Figures below represent piglets dying/total piglets challenged in 

each litter.

Vaccinates Controls

0/8 1/6

0/7 3/8

0/9 4/7

0/5 5/7

0/8 5/7

0/6 5/6

0/9 7/8

0/8 4/4

0/7 6/6

0/7 8/8

1/6

1/9

1/7

1/8

2/7

2/9

2/6

3/9

3/7

5/8

USDA Approval Date mm/dd/yyyy
Page 15 of 33

Example 9: 

Study Type Efficacy

Pertaining to Feline calicivirus

Study Purpose Demonstrate efficacy against feline calicivirus

Product 

Administration 

Two doses, administered subcutaneously, 3 weeks apart.

Study Animals 20 vaccinates and 10 controls, 9-11 weeks of age. 

Challenge 

Description 

Feline calicivirus was administered 3 weeks after the last vaccination. 

Interval observed 

after challenge

All cats were observed daily for clinical symptoms for 2 weeks after 

challenge. 

Results

Animals displaying clinical signs were considered to be affected by the 

challenge.

Number affected:

Vaccinates: 2/20

Controls: 10/10 

Raw data: 

A disease severity code was created. 

Clinical Observations Code

Normal A

Single shallow mouth ulcer B

Multiple distinct shallow ulcers, or an ulcer with deeper 

erosion C 

Mouth ulcers with excessive erosion D

Mouth ulcers with bleeding and/or salivation E

Mouth and/or nasal erosions with anorexia and 

depression F 

Labored breathing and/or pneumonia G

Data table is appended to end of this summary. 

USDA Approval 

Date

mm/dd/yyyy
Page 16 of 33
Page 17 of 33

Example 10: 

Study Type Safety

Pertaining to ALL

Study Purpose Demonstrate safety of product under typical use conditions.

Product Administration 2 Doses administered at 2 week intervals by either IM or SQ 

route. 

Study Animals 300 pigs ranging in age from 3 weeks to 12 weeks at each of 3 

sites. 1/3 were vaccinated intramuscularly (IM), 1/3 

subcutaneously (SQ), and 1/3 kept as controls. 1/3 of each 

treatment group were of minimum age recommended for product 

administration. 

Challenge Description NA

Observation interval 

after last treatment

Animals were observed every hour for 4 hrs after each injection 

and then twice daily through 14 days after the last vaccination. 

Results

Frequency of adverse 

events 

(150 total pigs per group) 

IM min ageIM othersSQ min ageSQ othersControl min ageControl others

Injection Site Swelling

(transient, ≤2 cm diameter) 

0 0 21 33 0 0

Respiratory Distress 0 0 0 1 0 0

Pain on injection 3 0 8 3 3 0

No adverse events 147 150 123 111 147 150

USDA Approval Date mm/dd/yyyy
Page 18 of 33

Example 11: 

Study Type Safety

Pertaining to ALL

Study Purpose Safety in pregnant mares 

Product Administration Two doses, administered intramuscularly, at a 3-week interval

Study Animals Pregnant mares, >2 years of age: separate groups vaccinated at 

each trimester of gestation. Similar sized groups in each trimester 

were maintained as controls.

Challenge Description NA

Interval observed after 

challenge

Observed through birth of foals

Results Treatment Vaccinated Confirmed 

pregnant

Healthy 

foals

1st trimester/product 200 178 169

1st trimester/control 196 181 170

2nd trimester/product 198 * 195

2nd trimester/control 190 * 185

3rd trimester/product 201 * 200

3rd trimester/control 196 * 196

*Pregnancy confirmed prior to enrollment in study.

USDA Approval Date mm/dd/yyyy
Page 19 of 33

Example 12: 

Study Type Safety

Pertaining to ALL

Study Purpose Demonstrate safety in pregnant gilts

Product Administration 1 dose, 5 weeks prior to farrowing

Study Animals Pregnant crossbred gilts: 75 vaccinated and 75 controls

Challenge Description NA

Interval observed after 

challenge

Observed from vaccination through farrowing. Litter size and 

health were documented.

Results No adverse events noted in gilts. See appended page for results 

of litter evaluation.

USDA Approval Date mm/dd/yyyy
Page 20 of 33

Control group:

Animal Live 

Births Dead Mummified Animal Live Births Dead Mummified

1 10 4 0 38 10 1 1

2 10 0 1 39 11 2 0

3 11 0 0 40 10 8 0

4 9 2 1 41 11 1 2

5 11 1 0 42 11 2 2

6 13 1 0 43 17 0 0

7 17 0 1 44 10 0 0

8 8 0 0 45 13 0 0

9 12 0 0 46 15 1 0

10 1 0 1 47 9 2 0

11 13 3 0 48 13 0 0

12 3 1 1 49 11 3 0

13 11 0 0 50 14 0 0

14 12 1 0 51 13 2 0

15 12 0 0 52 12 0 0

16 16 1 1 53 7 1 0

17 12 1 0 54 9 1 2

18 10 0 0 55 11 1 1

19 13 0 0 56 13 1 1

20 13 1 0 57 13 1 0

21 14 3 0 58 13 1 0

22 14 2 0 59 10 0 1

23 8 0 0 60 8 3 0

24 6 0 0 61 10 0 0

25 7 1 0 62 4 0 0

26 6 1 0 63 5 0 0

27 9 2 0 64 13 3 0

28 8 0 0 65 8 1 0

29 13 0 0 66 4 0 0

30 5 4 0 67 13 0 0

31 15 1 0 68 13 0 1

32 10 1 0 69 13 0 0

33 13 3 1 70 12 0 0

34 11 4 1 71 7 4 0

35 10 3 2 72 17 0 0

36 16 0 0 Total 775 83 24

37 10 3 3 Percentage 87.90% 9.40% 2.70%
Page 21 of 33

Vaccinate group:

Animal Live 

Births Dead Mummified Animal Live Births Dead Mummified

1 9 0 2 38 9 4 0

2 12 2 0 39 11 1 0

3 14 1 1 40 14 1 0

4 14 1 0 41 6 6 1

5 8 2 0 42 15 0 0

6 11 1 1 43 13 0 0

7 10 1 0 44 11 0 1

8 12 0 0 45 14 0 0

9 9 3 2 46 8 1 0

10 17 3 1 47 13 2 2

11 14 0 0 48 11 1 1

12 11 3 1 49 9 1 1

13 8 2 0 50 8 5 0

14 14 2 0 51 10 1 1

15 8 5 0 52 13 2 0

16 14 1 0 53 13 4 0

17 9 0 0 54 11 0 0

18 10 1 2 55 12 0 0

19 0 0 21 56 11 2 0

20 4 1 0 57 8 4 0

21 12 0 0 58 9 7 1

22 11 2 0 59 10 1 0

23 9 1 1 60 14 3 1

24 10 2 1 61 10 3 0

25 14 0 0 62 12 2 0

26 8 0 1 63 9 0 0

27 9 0 2 64 12 1 0

28 7 0 0 65 9 1 0

29 14 2 0 66 8 2 0

30 7 1 0 67 7 0 0

31 13 2 0 68 11 1 1

32 15 1 0 69 10 0 0

33 14 1 0 70 7 2 0

34 13 3 1 71 6 0 0

35 9 3 0 72 10 2 0

36 9 3 0 73 11 1 0

37 15 0 0 74 14 0 4
Page 22 of 33

Vaccinate group, continued:

Animal Live 

Births Dead Mummified Animal Live Births Dead Mummified

75 8 0 0 114 8 0 0

76 10 0 0 115 13 0 0

77 12 0 0 116 15 1 0

78 6 0 1 117 13 1 0

79 10 1 0 118 16 0 0

80 9 3 0 119 10 0 0

81 4 2 0 120 9 5 0

82 14 2 2 121 9 0 0

83 11 0 0 122 7 1 2

84 10 0 0 123 8 1 0

85 11 0 2 124 8 2 0

86 5 0 0 125 11 1 0

87 10 0 0 126 5 0 0

88 12 1 0 127 12 2 0

89 5 8 2 128 10 1 0

90 10 4 0 129 10 2 0

91 12 1 0 130 13 0 0

92 10 2 1 131 10 0 0

93 12 0 0 132 11 0 0

94 13 1 0 133 10 0 0

95 10 1 1 134 12 0 0

96 10 1 0 135 11 0 1

97 10 2 0 136 7 0 0

98 10 1 0 137 11 0 0

99 10 0 0 138 6 5 0

100 9 3 0 139 12 1 1

101 15 1 2 140 14 1 0

102 10 0 0 141 9 2 0

103 15 1 0 142 13 1 1

104 10 1 0 143 8 3 0

105 15 1 0 144 7 0 0

106 9 1 0 145 12 2 0

107 10 0 0 146 1 1 0

108 8 1 0 147 15 0 0

109 10 1 0 148 12 0 2

110 3 0 0 149 14 1 0

111 8 1 0 Total 1149 125 55

112 4 0 0 Percentage 85.78% 10.37% 3.85%

113 10 0 0
Page 23 of 33

Example 13: 

Study Type Efficacy

Pertaining to Marek’s Disease Virus serotype 1

Study Purpose Demonstrate efficacy against very virulent Marek’s disease

Product Administration One dose administered subcutaneously at 1 day of age

Study Animals Day-old chicks divided into 4 groups

Group 1 vaccinated with test product and challenged 

Group 2 sham vaccinated and challenged (control) 

Group 3 sham vaccinated non-challenged (control)

Group 4 vaccinated with a serotype 3 Marek’s vaccine and challenged 

(control) 

Challenge Description Serotype-1 (SR-1) RB1B strain administered at 4 days post 

vaccination

Interval observed after 

challenge

Observed daily for 7 weeks and then evaluated for internal lesions

Results Vaccinates and controls were evaluated in terms of Marek’s disease 

clinical signs and/or grossly observable lesions per the criteria in 

9 CFR 113.330(c)(4) & (5).

Birds with clinical signs and/or observable lesions:

Group 1: 5/34

Group 2: 31/34

Group 3: 0/35

Group 4: 8/33

Requirements of 9 CFR 113.330(c)(4) & (5) were met.

Raw data on attached page

USDA Approval Date January 1, 2008
Page 24 of 33

Raw data shown below for birds classified as positive. All other birds normal.

Tumors In

Group/Bird

EmaciationParalysisLocomotor/ KidneySpleenGonadsBreastLiverIntestineHeartAscitesInfectionYolk Sac GivenReason Not 

Group 1/1 x

Group 1/2 x

Group 1/3 x

Group 1/4 x x

Group 1/5 x

Group 2/1 x

Group 2/2 x x

Group 2/3 x x

Group 2/4 x x x

Group 2/5 x x x

Group 2/6 x x x

Group 2/7 x

Group 2/8 x x

Group 2/9 x x

Group 2/10 x

Group 2/11 x x

Group 2/12 x x

Group 2/13 x x

Group 2/14 x x x x

Group 2/15 x

Group 2/16 x

Group 2/17 x

Group 2/18 x x

Group 2/19 x x

Group 2/20 x x

Group 2/21 x

Group 2/22 x

Group 2/23 x x

Group 2/24 x x

Group 2/25 x x

Group 2/26 x

Group 2/27 x

Group 2/28 x

Group 2/29 x

Group 2/30 x
Page 25 of 33

Tumors In

Group/Bird

EmaciationParalysisLocomotor/ KidneySpleenGonadsBreastLiverIntestineHeartAscitesInfectionYolk Sac GivenReason Not 

Group 2/31 x

Group 4/1 x

Group 4/2 x x

Group 4/3 x x

Group 4/4 x x x

Group 4/5 x x x x

Group 4/6 x

Group 4/7 x

Group 4/8 x
Page 26 of 33

Example 14:

Study Type Safety

Pertaining to All fractions

Study Purpose Field safety

Product 

Administration 

Single dose by either the in ovo or subcutaneous (SQ) route.

Study Animals Commercial layer or broilers, at 18 day-old embryos (in ovo) or day-old chicks (SQ). 3 

independent study sites.

Challenge 

Description 

Not applicable

Interval 

observed after 

challenge

Layer pullets were observed for 8 weeks, Broiler chicks were observed until slaughter.

Results --For illustrative purposes, below are examples of acceptable formatting, depending on 

details of study design. They do not necessarily correspond to the design details listed 

above--

Location Treatment

Total 

Placed

21 Day 

Mortality

% 

Mortality

% 

Hatchability

% 

Condemnation

1 SQ 16,400 200 1.4 N/A 0.1

1 In ovo 16,400 205 1.6 86.9 0.05

1 Control 16,400 206 1.4 87.4 0.07

2 SQ 20,000 300 1.3 N/A 0.09

2 In ovo 20,000 303 2 87.8 0.12

2 Control 20,000 312 2 85.6 0.1

3 SQ 21,000 495 2.5 N/A 0.09

3 In ovo 21,000 480 2.2 90.2 0.04

3 Control 21,000 475 1.4 86.7 0.1

N/A is not applicable

Location Treatment

Total 

Placed

% 

Mortality

% 

Hatchability

% 

Condemnation

1 SQ 16,400 1.4 N/A 0.1

1 In ovo 16,400 1.6 86.9 0.05

1 Control 16,400 1.4 87.4 0.07

2 SQ 20,000 1.3 N/A 0.09

2 In ovo 20,000 2 87.8 0.12

2 Control 20,000 2 85.6 0.1

3 SQ 21,000 2.5 N/A 0.09

3 In ovo 21,000 2.2 90.2 0.04

3 Control 21,000 1.4 86.7 0.1

N/A is not applicable
Page 27 of 33

In ovo Route

SQ Route

No adverse reactions attributable to the vaccine were recorded.

USDA 

Approval Date

MMDDYYYY
Page 28 of 33

Example 15. 

Study Type Safety

Pertaining to ALL

Study Purpose Demonstrate safety of product under typical use conditions

Product 

Administration 

Two doses administered intramuscularly at a 3 week interval by IM route

Study Animals 675 cats total at 4 sites. Minimum age 8 weeks.

Challenge 

Description 

NA

Interval 

observed after 

challenge

Animals were observed for 1 hour after each injection and then daily for 

21 days.

Results

Injection site swellings were observed after the second vaccination and all resolved by 2 

days post vaccination. 

VeDDRA Code

Total 

number 

of 

animals

Percent of 

all animals

Normal 494 73.29%

Aggression 2 0.30%

Injection site self trauma 3 0.45%

Vocalization 3 0.45%

Lymphadenopathy 2 0.30%

General Pain 2 0.30%

Weakness 1 0.15%

Injection site swelling (cellulitis) 1 0.15%

Depression 33 4.90%

Ataxia 2 0.30%

Fever 10 1.48%

Tremor 2 0.30%

Injection site warmth 1 0.15%

Dyspnea 1 0.15%

Additional observations were affirmed by study cooperator to be due to causes other 

than vaccination.

Group 

at site

Total 

number 

animals

Maximum size of 

injection site reaction

Injection site 

reactions not

observed

< 0.5 cm 0.5-1.5 cm > 1.5 cm

1 200 5 7 0 188

2 200 2 8 0 190

3 200 10 6 0 184

4 75 10 9 2 53
Page 29 of 33

Example 16. 

Study Type Safety

Pertaining to ALL

Study Purpose Demonstrate safety under typical field conditions

Product Administration One dose 

Study Animals 900 pigs, 3 months of age, at three different geographical locations

Challenge Description Not Applicable

Interval observed after 

vaccination

Pigs were observed daily for 14 days following vaccination

Results Numbers of pigs by site with specific clinical observation postvaccination:

Clinical Observation

CA Site

N=300

GA Site

N=300

LA Site

N=300

None* 255 300 100

Depression 0 0 100

Loss of condition 2 0 35

Anorexia 5 0 75

Unthrifty 5 0 65

Decreased appetite 0 0 65

Abnormal breathing 0 0 100

Cough 0 0 100

*For “none”a pig had to be observed without clinical observations for the entire 14

days of the study. Observations at the LA Site were generally attributed to study pigs

unexpectedly experiencing an influenza outbreak at the beginning of the study.

USDA Approval Date MMDDYYYY
Page 30 of 33

Example 17: 

Study Type Efficacy

Pertaining to Herpesvirus, Bovine (IBR)

Study Purpose Efficacy against respiratory disease

Product Administration 

Study Animals 

Challenge Description 

Interval observed after 

challenge

Results Study data were evaluated by USDA-APHIS prior to product 

licensure and met regulatory standards for acceptance at the time 

of submission. No data are published because this study was 

submitted to USDA-APHIS prior to January 1, 2007, and APHIS 

only requires publication of data submitted after that date.

USDA Approval Date March 20, 2002
Page 31 of 33

Example 18: 

Study Type Efficacy

Pertaining to Equine influenza

Study Purpose Efficacy against Ohio 08 strain of equine influenza

Product Administration 

Study Animals 

Challenge Description 

Interval observed after 

challenge

Results This product class allows the manufacturer to update 

microorganisms in this vaccine under expedited procedures to 

respond to emerging needs. Abbreviated data to support 

influenza strain updates to the product composition were 

evaluated by USDA-APHIS and found to be acceptable based on 

regulations and policies at the time of approval. Full vaccinationchallenge studies may not have been required for these updates. 

USDA Approval Date March 20, 2010
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Example 19: Placeholder ISS for conditionally licensed platform products

Study Type Efficacy

Pertaining to Porcine circovirus type 2 (PCV2)

Study Purpose Efficacy against subtypes of PCV2 other than PCV2a

Product Administration 

Study Animals 

Challenge Description 

Interval observed after 

challenge

Results This product was qualified as a production platform based on 

demonstrated efficacy against PCV2a, as shown in the product 

compilation summary for Establishment 999, Code 

19K5.R6. As a platform product, the manufacturer may update 

the PCV gene insert in this vaccine under expedited procedures 

to respond to emerging needs. Abbreviated data to support these 

updates to the product composition were evaluated by USDAAPHIS and found to be acceptable based on regulations and 

policies at the time of approval. Full vaccination-challenge 

studies may not have been required for these updates. 

An identifier for the gene sequence variant found in a given 

serial (numbered batch) of vaccine is listed on product labeling.

USDA Approval Date January 31, 2018
Example 20: Placeholder ISS for prescription platform products

Study Type Safety

Pertaining to Prescription Platform Product

Study Purpose Safety

Product Administration Intramuscular

Study Animals Swine

Results This product was qualified as a prescription production platform 

based on demonstrated safety as shown in the Product Summary 

for Establishment 999, Code 1234.56. 

As a prescription platform product, the manufacturer may update 

the gene insert in this vaccine under expedited procedures to 

respond to emerging needs per Veterinary Services 

Memorandum 800.214. Study data to support these updates were 

evaluated by USDA-APHIS and found acceptable based on 

regulations and policies at the time of approval. Additional 

safety studies may not have been required for these updates.

An identifier for the gene sequence found in a given serial 

(numbered batch) of vaccine is listed on the product labeling.

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